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There has never been a more exciting time at Rani Therapeutics. We have successfully tested the RaniPill in humans, and we are working towards the ultimate goal of making the oral delivery of biologics a reality for millions of patients. We are growing rapidly and we are actively hiring.

Current Openings.

We are actively hiring and building our team. Check out some of our current open positions. If you think you have the right experience, and would like to be part of a dynamic team, we want to hear from you.

Vice President of Quality

Quality
GENERAL INFORMATION
Position Title: Vice President of Quality
Department: Quality
Purpose of the job
The Vice President of Quality is a key leadership role responsible for ensuring the highest quality standards, compliance, and regulatory adherence for Rani’s combination product. This role will maintain, strengthen, and mature the combination product Quality Management System (QMS) to meet regulatory expectations and support successful IND application submissions. This individual will lead the quality, and CMC functions across both pharmaceutical (drug) and medical device operations, ensuring compliance with FDA, cGMP, and global regulatory requirements, provides strategic direction for product development, and work closely with the operations and R&D teams to ensure seamless quality integration into the entire product lifecycle. This role requires an experienced subject matter expert in quality and regulatory compliance for combination products, as well as CMC leadership, with a strong background in managing FDA inspections and overseeing product development and manufacturing.
Major Duties and Responsibilities
Quality Leadership & Compliance
Establish and maintain a robust Quality Management System (QMS) to ensure compliance with GxP and FDA regulations (21 CFR part 4, 820, 210 & 211), ICH guidelines, ISO 13485 standard, and other regulatory body regulations and guidelines.
Lead and manage quality assurance (QA), quality control (QC), and compliance functions for combination product operations.
Lead preparation for and management of regulatory inspections, audits, and assessments, ensuring compliance with global regulatory guidelines such as the FDA, EMA, and ICH.
Lead and support Quality due diligences audit from potential and existing partners.
CMC Leadership
Provide strategic oversight for CMC activities, ensuring robust drug and device development, lifecycle management, and post-approval planning.
Develop a phase-appropriate CMC strategy.
Lead quality strategy for combination product development, ensuring alignment with regulatory expectations and best practices.
Partner with R&D, Operations and Clinical to drive quality into product development from early-stage development through commercialization.
Manufacturing Quality & Operational Excellence
Collaborate closely with manufacturing teams to ensure quality integration throughout production processes.
Guide and support technology transfer, process validation, and scale-up efforts, ensuring compliance with cGMP and regulatory requirements.
Implement quality risk management strategies to mitigate compliance risks and drive continuous improvement.
Guide Supply chain group ensuring external partners meet quality and regulatory standards.
Leadership & Team Development
Build and develop a high-performing quality and regulatory teams, including (QA, QC, and CMC).
Mentor and coach quality leaders and cross-functional teams to enhance technical expertise and regulatory knowledge.
Foster a collaborative and proactive quality culture that integrates seamlessly with product development and manufacturing operations.
Strong emotional intelligence, ability to influence across departments and build a sustain high performing culture.
Education and/or Job Experience
Advanced degree (PhD, MS, or MBA) in Life Sciences, Engineering, Regulatory Affairs, or related field.
Direct experience with INDs and combination product approvals.
Experience in late-stage clinical development and commercial product launch.
Skills and Specifications
15+ years of Quality leadership experience in the biopharmaceutical and/or combination product industry, with at least 5 years in an executive or senior leadership role.
Proven expertise in FDA regulations and supporting IND filings, cGMP and regulatory compliance for combination products.
Strong CMC experience, including leadership of drug and device development, validation, and manufacturing processes.
Deep understanding of ISO 13485, 21 CFR Part 820 (devices), 21 CFR Part 4 (combination products), 21 CFR Part 210/211 (pharmaceuticals), and ICH guidelines.
Strong leadership skills with the ability to influence and drive cross-functional collaboration in a fast-paced environment.
Key Competencies & Leadership Attributes
Strategic Vision – Ability to develop and implement long-term quality and regulatory strategies aligned with company goals.
Technical Acumen – Strong CMC knowledge to support drug/device development, manufacturing, and validation. Deep regulatory compliance understanding for combination products and ability to interface effectively with global health authorities.
Leadership & Influence – Proven ability to lead teams, build a quality-driven culture, and collaborate cross-functionally.
Operational Excellence – Ability to integrate quality principles into manufacturing, product development, and regulatory compliance.
Problem-Solving & Decision-Making – Strong analytical skills to assess compliance risks and implement proactive solutions.
Pay Range: $325,000 – $363,000 per year
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Administrative Assistant

Human Resources
General Information
Position Title: Administrative Assistant
Department: Human Resources
Reports to: Director of Human Resources
Summary
The Administrative Assistant (Part-Time) provides general administrative and office support to ensure smooth daily operations. This position assists with reception duties, scheduling, document management, ordering supplies, and supporting HR and facilities-related activities. The ideal candidate is organized, dependable, and demonstrates a proactive, service-oriented attitude.
Objectives of this Role
Support overall office operations and administrative functions with professionalism and efficiency.
Provide friendly and professional reception support for visitors and staff.
Maintain office organization, supplies, and records to promote an efficient work environment.
Assist with general administrative needs.
Help reinforce a positive and collaborative workplace culture through reliable support and strong communication.
Responsibilities
Duties include but are not limited to:
Greeting and assist visitors and employees in a courteous, professional manner.
Provide day-to-day administrative support including filing, scanning, correspondence, and mail distribution.
Maintain inventory of office supplies and coordinate reorders as needed.
Assist with meeting logistics including scheduling, room setup, catering, and materials preparation.
Support HR with company events.
Serve as a liaison with vendors and building services as directed.
Assist with maintaining appearance and organization of office common areas.
Support administrative tasks related to compliance, recordkeeping, and employee communications.
Provide general backup support to the Office Manager during absences or busy periods.
Education & Experience
Associate’s degree or equivalent experience preferred.
Minimum 1–2 years of administrative or office support experience; prior experience in a corporate environment a plus.
Basic understanding of HR or facilities functions desirable.
Professional Skills & Traits Required
Professional demeanor, dependable, and proactive.
Strong organizational and time-management skills.
Excellent verbal and written communication.
Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
Ability to maintain confidentiality and handle sensitive information.
Positive attitude, adaptable, and team oriented.
Work Environment
Onsite role. This position operates in a professional office environment using standard office equipment (computer, phone, copier, etc.).
Physical Demands
While performing the duties of this job, the employee is regularly required to talk and listen. The employee is required to stand, walk, and sit frequently.
This position requires the ability to occasionally lift office products and supplies, up to 20 pounds.
Position Type/Expected Hours of Work
Part-time, approximately 20-25 hours per week (schedule to be determined). Work hours will coincide with company’s office hours – 8:00 a.m. to 5 p.m.
Travel
May require some travel between offices – San Jose and Fremont. Not eligible for work from home.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Pay Range: $22 – $25 per hour
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Sr. Automation Lead/Manager

Automation Engineering
General Information
Position Title: Sr. Automation Lead/Manager
Department: Automation Engineering
Reports to: VP of Technical Operations

 

Purpose of the job
We are seeking an experienced Sr. Automation Lead/Manager to direct a team of automation engineers in developing and scaling cutting-edge automation solutions for high-volume medical device and life sciences manufacturing. This strategic leadership role focuses on deep automation core technology development, manufacturing scale-up, and driving operational excellence through advanced automated systems. The ideal candidate will combine strong technical expertise with exceptional leadership capabilities to build automation platforms that ensure regulatory compliance, precision, and efficiency in a highly regulated environment. This is a hands-on position that requires interaction and collaboration with a cross-functional team including Engineering, Manufacturing, Biology, Quality, Facilities, and Sustaining.

Major Duties and Responsibilities
Strategic Leadership & Technology Development
Lead the development and execution of the site automation master plan and roadmap aligned with organizational goals and industry standards.
Drive innovation in automation core technologies including DCS, PLC, SCADA systems, robotics integration, and Industry 4.0 platforms to support high-volume production.
Establish automation strategies that enable continuous manufacturing, process optimization, and scalability for medical device production.
Oversee the architecture, design, and implementation of automated systems from concept through validation, ensuring solutions meet both current and future manufacturing demands.​

Team Leadership & Development
Lead, mentor, and develop a high-performing team of automation engineers by fostering collaboration, continuous learning, and technical excellence.
Provide coaching, identify skill gaps, and offer professional development to promote growth and strengthen competencies.
Empower team members by setting clear roles, goals, and expectations using frameworks like OKRs and SMART goals, while ensuring accountability and alignment.
Coordinate closely with cross-functional teams, external partners, and key stakeholders to achieve project objectives on time and within budget.
Facilitate regular meetings, establish effective communication channels, and maintain good design control practices through detailed project planning.
Serve as the technical liaison, promoting transparency and translating technical requirements into business outcomes.

Automation Vendor Management
Establish and manage strategic relationships with automation vendors, equipment suppliers, contract manufacturers, and technology partners.
Lead vendor selection, procurement, and onboarding processes for capital equipment including robotics, vision systems, PLCs, and automated assembly systems.
Oversee vendor performance monitoring, contract compliance, and service-level agreements to ensure quality deliverables and cost-effectiveness.
Coordinate with vendors on system integration, qualification activities, and lifecycle management to maintain supportability and mitigate obsolescence risks.​​

Scale-Up & Manufacturing Excellence
Drive automation initiatives to scale production from pilot to high-volume manufacturing while maintaining quality, compliance, and throughput targets.
Develop digital twins, takt-time modeling, and throughput optimization strategies to maximize line efficiency and minimize downtime.
Evaluate the current manufacturing processes & workflows, identify opportunities for improved performance/throughput by applying knowledge of product design, fabrication, assembly, tooling, and materials as well as soliciting feedback from operators.
Lead root cause investigations for automation-related issues and implement corrective and preventive actions to drive continuous improvement.​

Regulatory Compliance & Quality Systems
Ensure all automation solutions comply with FDA regulations, ISO 13485, cGMP, 21 CFR Part 11, and other applicable quality management standards.
Take full ownership of the design, create User Requirements Specification (URS), conduct concept reviews, show proof of concept through prototyping/supporting test data, coordinate with appropriate stakeholders for successful verification/validation, launch, and documentation.
Oversee creation and execution of FAT, SAT, and validation protocols (IQ/OQ/PQ), design controls, and documentation in accordance with regulatory requirements.
Implement automated compliance monitoring, traceability systems, and electronic batch records to enhance audit readiness and reduce compliance risk.
Maintain lifecycle management of automation systems ensuring all platforms remain on supported, validated configurations.​​

Project & Resource Management
Develop detailed project plans with clear timelines, milestones, resource requirements, and deliverables using structured project management methodologies.
Manage CAPEX and OPEX budgets for automation initiatives, ensuring cost-effective solutions and strong return on investment.
Balance multiple priorities across concurrent projects, effectively allocating resources and managing dependencies.
Track and report on key performance metrics including first-pass yield, uptime, cycle time, and automation ROI.
Take full ownership of the design, create User Requirements Specification (URS), conduct concept reviews, show proof of concept through prototyping/supporting test data, coordinate with appropriate stakeholders for successful verification/validation, launch, and documentation.

Education and/or Job Experience
Bachelor’s Degree in Mechanical, Electrical, Biomedical Engineering or equivalent.
5 – 10 years hands-on leadership relevant experience.
In-depth experience with complex mechanical/electromechanical design.
Extensive experience with precision mechanisms, pneumatics, servo systems, tooling/fixtures, and mechanical components such as motors, belts/pulleys, gears, actuators, sensors, etc.
Experience with creating engineering drawings, BOMs and product specifications.
Deep knowledge of material properties, heat treatment, and surface finish.
Proven track record with Medical Device Manufacturing Methods/Procedures, FDA regulations, ISO, cGMP, and QMS standards.
Good understanding of DFM and lean manufacturing.
Excellent verbal, written, presentation and interpersonal skills.
Strong analytical and problem-solving skills.
Knowledge and/or hands-on experience with machine shop tools.
Deep knowledge of GD&T as well as proficiency with SolidWorks.
Creative, self-motivated and flexible to work in a small company environment and assume a wide variety of tasks.
Preferred Qualifications
Master’s degree in Mechanical Engineering or equivalent.
Knowledge/experience with plastic injection molding.
Knowledge/experience with DOE, SPC, JMP /Minitab.
Experience with metal stamping, laser cutting and chemical etching.
Familiarity with and sterilization process and aseptic environment.
PLC programming, SCADA, Ladder Logic preferred.
Pay Range: $180,000 – $215,000 per year
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Sr. Manufacturing Process Engineer

Manufacturing
Position Title: Sr. Manufacturing Process Engineer
Department: Manufacturing
Purpose of the Job
The Sr. Manufacturing Process Engineer supports and leads advanced manufacturing activities for Rani Capsules. This role provides technical leadership in developing, revamping, and optimizing manufacturing processes and equipment. The engineer collaborates with R&D, Quality, and Operations teams to ensure product specifications conform to regulatory and business requirements, while driving innovation, efficiency, and compliance across production lines. The position also contributes to policy development and process standardization, ensuring alignment with strategic business objectives.
Major Duties and Responsibilities
Lead the design, implementation, and continuous improvement of complex manufacturing processes, ensuring scalability, reliability, and cost-effectiveness.
Revamp entire manufacturing workflows to enhance productivity, quality, and compliance while reducing cost and labor.
Conduct advanced process capability studies and Design of Experiments (DOEs); utilize statistical analysis software (Minitab, JMP) to interpret results and propose actionable improvements.
Develop new process policies, procedures, and standards that improve cross-departmental efficiency and regulatory robustness.
Mentor and guide junior engineers by reviewing work, providing feedback, and delegating subprojects within larger manufacturing initiatives.
Contributes to and influences strategic decisions impacting manufacturing and product delivery.
Design and execute process validation protocols (IQ, OQ, PQ) at manufacturing scale; collaborate with Quality and Validation departments to meet business demands.
Troubleshoot complex manufacturing issues through root cause analysis, coordinating with multidisciplinary teams to implement sustainable corrective actions.
Drive cross-functional initiatives to ensure manufacturing processes align with R&D, Quality, and Supply Chain objectives.
Analyze high-complexity data sets to monitor process performance, identify improvement areas, and optimize throughput and yield.
Develop and maintain comprehensive manufacturing documentation, including MPIs, LHRs, and WIs, ensuring consistency and compliance with QMS standards.
Represent Manufacturing Engineering in strategic discussions, providing technical recommendations that influence broader business and operational decisions.
Promotes open exchange of ideas, feedback, and collaboration across departments and teams.
Serves as a representative of the company, demonstrating accountability and acting in its best interest.
Qualifications
Bachelor’s Degree in Mechanical, Chemical, Manufacturing or related engineering fields
6-8 years hands-on experience in a manufacturing environment with proven track record of process development /optimization and validation
Excellent verbal, written, presentation and interpersonal skills
Prior experience with FDA regulations and ISO, cGMP, QMS standards, etc.
Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks
Strong analytical and problem-solving skills including but not limited to DOE, and statistical data analysis
Extensive experience with process capability studies, FMEA, PPK, GR&R, SPC and process development/validation
Knowledge and experience with plastic injection molding as well as semi-automated and fully automated machines /processes
Knowledge of material science and polymer chemistry
Diverse background in process characterization and optimization in a manufacturing environment.
Hands-on proactive approach to problem solving
Requires interaction and collaboration with a cross-functional team
Preferred Qualifications
Experience with Statistical Software tools such as Minitab or JMP
Knowledge and/or hands-on experience with metrology tools such as CMM, Micro-Vu, SEM, etc.
Familiarity with cleaning and sterilization processes
Working knowledge of SolidWorks

 

Pay Range: $155,000 – $180,000 per year
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MANUFACTURING PROCESS ENGINEER

Manufacturing
General Information
Position Title: Manufacturing Process Engineer
Department: Manufacturing
Reports to: Senior Manager, Manufacturing

 

Position Overview
The Manufacturing Process Engineer plays a critical role in supporting the manufacturing of Rani Capsules. This role involves providing technical assistance in the installation, preventative maintenance, and calibration of equipment, as well as ensuring process improvements and consistency in manufacturing operations. The position works closely with R&D engineering and quality teams to ensure device specifications align with device requirements.

 

Key Responsibilities
  • Actively support NPI by working hands-on on the production floor to troubleshoot issues, stabilize yields, and drive smooth transitions from development to full-scale manufacturing.
  • Collaborate with Development and R&D Engineers to execute effective design transfer, process characterization, and ramp plans.
  • Conduct process capability studies and apply DOE, SPC, and data-driven analysis to draw conclusions, implement improvements, and sustain gains.
  • Develop standard work, process controls, and monitoring methods to reduce variability across operators, materials, equipment, and workflows.
  • Investigate process deviations and failures; perform structured root cause analysis (5-Why, Fishbone, FMEA) and implement robust corrective and preventive actions (CAPA).
  • Proactively identify opportunities for improvement and challenge assumptions constructively to drive better outcomes.
  • Create and execute IQ/OQ/PQ and related verification and validation protocols, analyze results, and generate complete documentation and reports.
  • Ensure compliance with design control, validation, documentation, and change-control policies (FDA, ISO, cGMP, QMS).
  • Create and maintain clear, complete manufacturing documentation (MPIs, LHRs, WIs, forms, checklists) that reflect current practices and controls.
  • Train and guide technicians and assemblers; drive best practices and foster a culture of safety, quality, and continuous improvement.
  • Contribute to design-for-manufacturability (DFM), cost reduction, quality improvement, and automation initiatives.
  • Cultivate a mindset of ownership and innovation, where individuals actively seek out challenges and collaborate across teams to solve them
Experience
  • 3–7 years of hands-on experience in a manufacturing environment, with a proven track record in process development, optimization, and validation.
  • Extensive experience with process capability studies, FMEA, PPK, GR&R, SPC, and process development/validation.
  • Knowledge and experience with plastic injection molding as well as semi-automated and fully automated machines/processes
  • Proven ability to perform statistical data analysis and implement improvement plans using DOE and other methods.
  • Strong analytical and problem-solving skills including but not limited to DOE, and statistical data analysis
  • Knowledge of material science and polymer chemistry
  • Diverse background in process characterization and optimization in a manufacturing environment.
  • Experience with FDA regulations and ISO, cGMP, and QMS standards.
  • Experience with Statistical Software tools such as Minitab or JMP
  • Familiarity with cleaning and sterilization processes
  • Working knowledge of SolidWorks
Education
  • Bachelor’s Degree in Mechanical, Chemical, Manufacturing, or a related engineering field.
  • Relevant certifications as pertains to the position (e.g., Six Sigma, Lean Manufacturing, etc.) is a plus.
  • Proficiency in Microsoft Excel, Microsoft Word, and other engineering software tools.
  • Familiarity with metrology tools such as CMM, Micro-Vu, SEM, etc. is a plus.
Physical Demands
  • The employee is regularly required to stand, walk, and sit for extended periods during the performance of job duties.
  • Must be able to physically be present on-site to perform the required tasks.

 

Pay Range: $137,000 – $160,000 per year

Apply

Sr. Manufacturing Process Engineer

Manufacturing
General Information
Position Title: Sr. Manufacturing Process Engineer
Department: Manufacturing
Reports to: Process Engineering Department
Position Overview
The Sr. Manufacturing Process Engineer supports and leads advanced manufacturing activities for Rani Capsules. This role provides technical leadership in developing, revamping, and optimizing manufacturing processes and equipment. The engineer collaborates with R&D, Quality, and Operations teams to ensure product specifications conform to regulatory and business requirements, while driving innovation, efficiency, and compliance across production lines. The position also contributes to policy development and process standardization, ensuring alignment with strategic business objectives.
Major Duties and Responsibilities
  • Lead the design, implementation, and continuous improvement of complex manufacturing processes, ensuring scalability, reliability, and cost-effectiveness.
  • Revamp entire manufacturing workflows to enhance productivity, quality, and compliance while reducing cost and labor.
  • Conduct advanced process capability studies and Design of Experiments (DOEs); utilize statistical analysis software (Minitab, JMP) to interpret results and propose actionable improvements.
  • Develop new process policies, procedures, and standards that improve cross-departmental efficiency and regulatory robustness.
  • Mentor and guide junior engineers by reviewing work, providing feedback, and delegating subprojects within larger manufacturing initiatives.
  • Contributes to and influences strategic decisions impacting manufacturing and product delivery.
  • Design and execute process validation protocols (IQ, OQ, PQ) at manufacturing scale; collaborate with Quality and Validation departments to meet business demands.
  • Troubleshoot complex manufacturing issues through root cause analysis, coordinating with multidisciplinary teams to implement sustainable corrective actions.
  • Drive cross-functional initiatives to ensure manufacturing processes align with R&D, Quality, and Supply Chain objectives.
  • Analyze high-complexity data sets to monitor process performance, identify improvement areas, and optimize throughput and yield.
  • Develop and maintain comprehensive manufacturing documentation, including MPIs, LHRs, and WIs, ensuring consistency and compliance with QMS standards.
  • Represent Manufacturing Engineering in strategic discussions, providing technical recommendations that influence broader business and operational decisions.
  • Promotes open exchange of ideas, feedback, and collaboration across departments and teams.
  • Serves as a representative of the company, demonstrating accountability and acting in its best interest.
Qualifications
  • Bachelor’s Degree in Mechanical, Chemical, Manufacturing or related engineering fields
  • 6-8 years hands-on experience in a manufacturing environment with proven track record of process development /optimization and validation
  • Excellent verbal, written, presentation and interpersonal skills
  • Prior experience with FDA regulations and ISO, cGMP, QMS standards, etc.
  • Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks
  • Strong analytical and problem-solving skills including but not limited to DOE, and statistical data analysis
  • Extensive experience with process capability studies, FMEA, PPK, GR&R, SPC and process development/validation
  • Knowledge and experience with plastic injection molding as well as semi-automated and fully automated machines /processes
  • Knowledge of material science and polymer chemistry
  • Diverse background in process characterization and optimization in a manufacturing environment.
  • Hands-on proactive approach to problem solving
  • Requires interaction and collaboration with a cross-functional team
Preferred Qualifications
  • Experience with Statistical Software tools such as Minitab or JMP
  • Knowledge and/or hands-on experience with metrology tools such as CMM, Micro-Vu, SEM, etc.
  • Familiarity with cleaning and sterilization processes
  • Working knowledge of SolidWorks

Pay Range: $155,000 – $180,000 per year

Apply

Quality Inspector

Quality
General Information
Position Title: Quality Inspector (II, III, or Senior)
Department: Quality
Reports to: Quality Engineering
Position Overview
This Quality Inspector position will report to Quality Engineering. Main responsibilities include performing incoming inspections of materials/parts/products and reviewing and approval of manufacturing batch records and inspection records. This position will require to perform disposition of materials/parts/products.  As a Quality Inspector, you will also support Quality Engineering with other Quality Management System (QMS) activities, such as assisting with environmental monitoring and quality metrics.
Major Duties and Responsibilities
  • Interpret drawings and specification documents.
  • Perform incoming inspection of materials/components/subassemblies/finished products following standard operating procedures and using standard inspection tools, including the MicroVu and Keyence.
  • Determine inspection sample size based on procedures, specifications, and standards.
  • Help develop inspection methods, including automated inspection programs using the MicroVu and Keyence.
  • Review/approve executed batch records for manufacturing and inspection records in accordance to QMS procedures and Good Documentation Practices.
  • Approve/perform final disposition of materials/components/subassemblies/finished products.
  • Assign and apply expiration dating labels to materials/parts/products, as per specifications/quality procedures.
  • Initiate Non-Conformance Material Reports (NCMRs) and deviations when discrepancies are observed during inspections and record review process. Report discrepancies and issues to QA Engineering and affected function(s).
  • Maintain materials in Quarantine (pending disposition) and MRB (under NCMR and deviations) in order.
  • Maintain accurate records as per Document Control procedures.
  • Support training of IQC personnel.
  • Assist with performing environmental monitoring of Controlled Environment Rooms (CERs), as needed.
  • Support Quality in the collection of quality metrics data.
  • Interact closely with different functions of the organization.
EDUCATION AND/OR JOB EXPERIENCE
  • 2-5 years of experience performing inspections and reviews/approvals of manufacturing batch records/inspection records
  • Government Regulated Environment experience such as FDA and ISO 13485
  • Must have adequate computer experience (knowledge of Microsoft Word, Excel)
  • Experience working in a cGMP environment
Skills and Specifications
  • Attention to detail and organizational skills
  • Good interpersonal and communication skills
  • Ability to work as a part of a team and promote a team environment

 

Pay Range: $37 – $42 per hour

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Quality Specialist

Quality
General Information
Position Title: Quality Specialist
Department: Quality
Reports to: Quality Engineering
Position Overview
This Quality Specialist position will report to Quality Engineering and will support various areas of the Quality Management System (QMS). Main responsibilities include performing inspections of parts/materials/products and the review and approval of manufacturing batch records and inspection records. This position will require to perform disposition of materials/parts/products.  As a Quality Specialist, you will also support Quality Engineering with other Quality Management System (QMS) activities, such equipment calibration/maintenance, environmental monitoring, purchasing supplies/equipment, shipping samples for testing, quality metrics, and SOP updates to maintain compliance with QMS procedures.
Major Duties and Responsibilities
  • Interpret drawings and specification documents.
  • Perform incoming inspection of materials/components/subassemblies/finished products following standard operating procedures and using standard inspection tools, including the MicroVu and Keyence.
  • Determine inspection sample size based on procedures, specifications, and standards.
  • Help develop inspection methods, including automated inspection programs using the MicroVu and Keyence.
  • Review/approve executed batch records for manufacturing and inspection records in accordance to QMS procedures and Good Documentation Practices.
  • Approve/perform final disposition of materials/components/subassemblies/finished products.
  • Assign and apply expiration dating labels to materials/parts/products, as per the specifications/quality procedures.
  • Initiate Non-Conformance Material Reports (NCMRs) and deviations when discrepancies are observed during inspections and record review process. Report discrepancies and issues to QA Engineering and affected function(s). Work with NCMR and deviation owners to ensure action plans are completed in a timely manner.
  • Maintain materials in Quarantine (pending disposition) and MRB (under NCMR and deviations) in order.
  • Maintain accurate records as per Document Control procedures.
  • Coordinate IQC priorities and monitor IQC tasks and deliverables.
  • Support training of IQC personnel.
  • Handling and shipping of samples to external testing laboratories.
  • Assist in the coordination of equipment preventative maintenance and calibration and maintaining equipment files.
  • Assist with performing environmental monitoring of Controlled Environment Rooms (CERs).
  • Review and update Standard Operating Procedures (SOPs) to ensure compliance with the QMS.
  • Support Quality in the collection of quality metrics data and data monitoring.
  • Assist QA during quality audits.
  • Interact closely with different functions of the organization.
  • Performs other duties as needed to support the Quality Assurance Department and the company.
EDUCATION AND/OR JOB EXPERIENCE
  • Minimum of 5-6 years of related work experience, especially performing inspections and reviews/approvals of manufacturing batch records/inspection records.
  • Government Regulated Environment experience such as FDA and ISO 13485
  • Must have adequate computer experience (knowledge of Microsoft Word, Excel)
  • Experience working in a cGMP environment
Skills and Specifications
  • Attention to detail and organizational skills
  • Good interpersonal and communication skills
  • Ability to work as a part of a team and promote a team environment

 

Pay Range: $45 – $52 per hour

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Senior Quality Engineer

Quality
General Information
Position Title: Senior Quality Engineer
Department: Quality
Reports to: Sr. VP of Quality
Purpose of the job
The Sr. Quality Engineer supports the Design and Development group and Operations to ensure combination products, components, and materials in development comply with Rani SOP’s and applicable regulatory requirements. The ideal candidate will have working knowledge in the design control requirements for medical device and hands-on experience in product life cycle, from feasibility prototype through product commercialization. The Sr. QE will provide quality and compliance input to the project team for project decisions and deliverables (e.g., Product Specifications, Test Methods, Design Reviews, Design V&V, Usability Testing, SW Validation, Process Validation). The candidate shall have the capacity to prioritize project activities and work within a multidisciplinary team.
Major Duties and Responsibilities
  • This individual will be responsible for supporting the Product Lifecycle, Design Control, and Design Transfer processes, as well as the quality elements of design projects
  • Provide quality assurance oversight and ensure compliance in the support of combination device development life cycles
  • Ensure product development projects and changes to existing products are conducted in compliance with the Quality System Regulations
  • Lead risk management activities and participate in cross-functional teams to develop and maintain Product Risk Management Files (Risk Management Plan & Report, HA, UFMEA, DFMEA, PFMEA, etc.)
  • Lead test method validation activities and Gage R&R studies for Combination Product
  • Oversee calibration and preventive maintenance program
  • Apply knowledge of Design Control principles and quality engineering to positively influence new product development efforts, including establishing, reviewing, and approving design inputs/outputs, Design Verification & Validation, Process Characterization & Validation, Component Qualification
  • Identify quality characteristics and validation criteria for components, subassemblies, and finished product
  • Work with R&D in the creation of requirements for new products and engineering specifications
  • Responsible for assuring design projects meet quality goals, and regulatory requirements including FDA Quality System Regulations, ISO 13485, EU MDR requirements, and Risk Management per ISO 14971
  • Provides direction to Engineering to establish, implement, and maintain policies and procedures designed to ensure compliance with all necessary and appropriate quality standards within the area of Design Controls
  • Serve as a technical resource for assessing validation requirements, solving test related problems, and developing preventive strategies
  • Assist in the development and approval of design development plans, verification and validation protocols, reports, master V&V plans and reports
  • Support quality assurance activities, including, but not limited to: internal and external audits, NCMRs and CAPAs,
  • Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ)
  • Other duties/ activities may be necessary to support departmental or company goals
Education and/or Job Experience                                                                                                                       
  • A minimum of 8 years quality assurance/engineering in a regulated industry (medical device,) is required
  • BS degree in Mechanical Engineering or related field is required
  • Demonstrated competency with Medical Devices Design Controls, 21 CFR 820, MDR, ISO 13485
  • Experience with Risk Management process (Risk Management Plan/Report, FMEA’s) and associated standards (ISO 14971:2019)
  • Understanding of multiple technological areas (software, mechanical, electrical, biomedical, test automation, etc.)
  • Must be a self-starter and capable of working independently and within a team.
  • Experience performing statistical analysis (Six Sigma preferred)
  • CQE, CQA preferred
Skills and Specifications
  • Ability to motivate and influence people
  • Must possess the ability to handle multiple tasks with high attention to detail Organizing, planning, and problem-solving skills
  • Good interpersonal and communication skills
  • Ability to work as a part of a team
  • Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports
  • Ability to create and provide training
  • Good statistical and numerical ability
  • Exceptional problem-solving skills

Understands and can subsequently explain complex quality details to non-expertsPay Range: $150,000 – $190,000 per year

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Quality Engineer

Quality
General Information
Position Title: Senior Quality Engineer
Department: Quality
Reports to: Sr. VP of Quality
Purpose of the job
The Quality Engineer supports compliance with applicable regulatory requirements by maintaining an effective quality management system and implementing continuous improvements. This position is responsible for activities ranging from product development through commercialization. This is a hands-on role where the Quality Engineer will apply diversified knowledge of engineering, quality principles and practices for medical devices and combination products. This position also ensures that the company complies with all applicable federal, industry, and company procedures, guidelines, and regulations during the receipt, storage, manufacture, and distribution of products.
Major Duties and Responsibilities
  • Maintain and improve the quality system in accordance with FDA Quality System Regulation and ISO 13485 requirements
  • Support quality assurance activities, including, but not limited to: Risk Management (FMEAs, HA), internal and external audits, NCMRs and CAPAs
  • Investigate product quality problems and determine root cause, gather and analyze data, and implement corrective actions to reduce or eliminate cause
  • Manage the Non-conforming Materials Review (NCMR) in collaboration with Operations to ensure timely reporting, analysis, and resolution of non-conforming material
  • Lead the resolution of quality issues related to non-conformance reports and CAPAs
  • Support Operations team in the maintenance and continuous improvement of product and manufacturing processes
  • Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ).
  • Provide QE support to production, purchasing and engineering
  • Support/lead test method validation activities
  • Conduct and support the development and validation of appropriate test methods for product and process performance
  • Develop and initiate sampling procedures and statistical process control methods
  • Support product line manufacturing and design stages by ensuring validation of manufacturing equipment and processes are conducted in accordance with the Validation Master Plan
  • Address systemic quality issues with suppliers or internal groups
  • Assist in the review of lot history records and disposition of product (subassembly and finished goods)
  • Work with process and R&D engineers to develop adequate inspection criteria
  • Perform statistical analysis such as capability, gage R&R, and statistical process control
  • Evaluate product changes for qualification and validation requirements and assist in change implementations
  • Other duties/ activities may be necessary to support departmental or company goal
Education and/or Job Experience
  • A minimum of 6 years quality assurance/engineering experience is required. Experience in a regulated industry (medical device,) is required
  • BS degree in Engineering is required
  • Experience with FDA Quality System Regulations and ISO Standards (ISO 13485 and ISO 14971) is required
  • Experience with non-conformances, CAPA, and Risk Management is required
  • Experience in performing test method validation and Gage R&Rs
  • Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes)
  • CQE, CQA preferred
Skills and Specifications
  • Ability to motivate and influence people
  • Must possess the ability to handle multiple tasks with high attention to detail Organizing, planning, and problem-solving skills
  • Good interpersonal and communication skills
  • Ability to work as a part of a team
  • Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports
  • Ability to create and provide training
  • Good statistical and numerical ability
  • Exceptional problem-solving skills
  • Understands and can subsequently explain complex quality details to non-experts

Pay Range: $130,000 – $160,000 per year

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