Last updated: 2025-05-22

57 Quality Engineering jobs in San Jose.

Hiring now: Dir Regulatory Document Q @ Exelixis, Regulatory Affairs Coordi @ Penumbra, Manufacturing Eng Mgr @ Penumbra, Sr Quality Engr @ Penumbrain, Medical Devices Quality M @ Meta, Medical Devices Quality M @ Facebook R, Clinical Proj Mgr @ Neuralink, Sr Quality Engr Reagents @ Ultima Gen, Principal Rd Tech Claims @ Johnson Jo, Sr Engr Design Quality @ Stryker.Explore more at at kaamvaam.com

🔥 Skills

ISO 13485 (9) Quality Assurance (9) project management (8) medical devices (7) medical device (7) regulatory requirements (6) compliance (6) cross-functional teams (5) SOPs (5) Compliance (5)

📍 Locations

San Jose (13) Alameda (8) Hayward (8) Fremont (6) Redwood City (4) San Carlos (4) Palo Alto (3) Burlingame (2) Milpitas (2) Oakland (2)
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Exelixis

Director, Regulatory Document Quality Control Alameda
Skills & Focus: regulatory submissions, quality control, pharmaceutical industry, clinical development, oncology, data analysis, cross-functional teams, SOPs, document management, project management
About the Company: Exelixis is focused on treating cancer, providing access to investigational therapies, and innovating in research and development.
Experience: Minimum of thirteen years of related experience with a BS/BA degree; eleven years with MS/MA; or eight years with a PhD in a life science-related discipline.
Salary: $196,000 - $278,000
Type: Full-time
Benefits: 401k plan with contributions, medical, dental, vision coverage, life insurance, flexible spending accounts, discretiona…

Penumbra

Regulatory Affairs Coordinator Alameda
Skills & Focus: Regulatory Affairs, medical devices, 510(k) submissions, CE-Mark, Quality System regulations, ISO 13485, Design Control, Regulatory Intelligence, interpersonal communication skills, organizational skills
Experience: 2+ years of experience
Salary: $86,000 - $116,000 / year
Type: Full-time
Benefits: Competitive compensation package plus benefits and equity program

Exelixis

Vice President, Pharmacovigilance Alameda
Skills & Focus: pharmacovigilance, case management, regulatory requirements, safety systems, quality management, adverse events, global reports, data analytics, compliance operations, supervisory experience
About the Company: Exelixis is dedicated to advancing the discovery and development of innovative treatments for cancer and providing access to investigational therapies.
Experience: Minimum of 17 to 21 years of experience depending on education level.
Salary: $351,500 - $408,000 annually
Type: Full-time
Benefits: Comprehensive employee benefits package, including a 401k plan with company contributions, group medical, dental and vi…

Penumbra, Inc.

Manufacturing Engineering Manager Alameda
Skills & Focus: manufacturing engineering, project management, quality system, medical device, process development, team leadership, cost effectiveness, product quality, GMP regulations, engineering support
About the Company: A medical device company focused on innovative technologies to treat and manage challenging medical conditions.
Experience: 5+ years of relevant experience
Salary: $145,000 - $214,000
Type: Full-time

Penumbrainc

Senior Quality Engineer Alameda
Skills & Focus: Quality Assurance, ISO, Engineering, Manufacturing, Design Control, Statistical Analysis, Compliance, Medical Devices, Regulated Industry, Project Management
Experience: 5+ years of relevant experience
Salary: $125,000 to $175,000

Penumbra, Inc.

Quality Engineer II Alameda
Skills & Focus: Quality Engineering, Medical Devices, Quality Management System (QMS), Regulatory Compliance, ISO Standards, Testing Methodology, Failure Analysis, Inspection Procedures, Statistical Techniques, Collaboration
About the Company: Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures,…
Experience: 2+ years of quality engineering or relevant experience, preferably in a medical devices or regulated industry environment.
Salary: $95,000 to $127,000
Type: Full-time
Benefits: A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-te…

Exelixis

Associate Regulatory Affairs CMC Director Alameda
Skills & Focus: Regulatory Affairs, CMC, submissions, compliance, INDs, IMPDs, NDA, BLA, cross-functional teams, regulatory guidance
About the Company: Exelixis is focused on developing and commercializing innovative cancer therapies.
Experience: Minimum of five years related experience with a PhD, or nine years with a Master's degree, or eleven years with a Bachelor's degree.
Salary: $158,000 - $224,500 annually
Type: Full-time
Benefits: 401k plan, group medical, dental and vision coverage, life and disability insurance, flexible spending accounts, discre…
Operations QA Manager - Commercial Alameda
Skills & Focus: GMP Operations, Quality Assurance, Clinical Trials, Contract Manufacturing Organizations, Vendor Management, Regulatory Requirements, Documentation Review, Pharmaceutical Industry, Investigations Coordination, Quality Compliance
About the Company: Exelixis is focused on developing innovative cancer medicines and providing access to investigational therapies.
Experience: 7 years related experience with BS/BA, 5 years with MS/MA, or 0 years with PhD.
Salary: $112,000 - $158,000 annually
Type: Full-time
Benefits: 401k plan with generous contributions, group medical, dental and vision coverage, life and disability insurance, flexib…

Meta

Medical Devices, Quality Management Systems Engineer Burlingame
Skills & Focus: Quality Management System, QMS, ISO 13485, Regulatory Affairs, Quality Engineering, Compliance, Internal Audits, CAPA, Electromechanical Devices, Software as a Medical Device (SaMD)
About the Company: Meta builds technologies that help people connect, find communities, and grow businesses. When Facebook launched in 2004, it changed the way people connect. Ap…
Experience: 3+ years of experience in a highly regulated industry (e.g., Medical Devices, Bioengineering, Pharma, Life Sciences, Quality and/or Development)
Salary: $102,000/year to $164,000/year + bonus + equity + benefits
Type: Full Time
Benefits: Meta offers benefits, including compensation details like bonus, equity, and sales incentives in addition to base compe…

Facebook Reality Labs

Medical Devices, Quality Management Systems Engineer Burlingame
Skills & Focus: Quality Management System (QMS), 21 CFR, ISO 13485, Electromechanical devices, Software as a Medical Device (SaMD), Regulatory compliance, Internal audits, CAPA, Continuous improvement, Key Process Indicators (KPIs)
About the Company: Meta builds technologies that help people connect, find communities, and grow businesses. When Facebook launched in 2004, it changed the way people connect. Ap…
Experience: 8+ years of work experience in a highly regulated industry (e.g., Medical Devices, Bioengineering, Pharma, Life Sciences, Quality and/or Development)
Salary: $170,000/year to $240,000/year + bonus + equity + benefits
Type: Full Time
Benefits: Meta offers benefits including health, wellness resources, and compensation determined by skills, qualifications, and e…

Neuralink

Clinical Project Manager Fremont
Skills & Focus: clinical trials, clinical studies, Good Clinical Practice, compliance, medical devices, ISO14155, communication, project management, neuroscience, regulatory requirements
About the Company: We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to th…
Experience: 5+ years of academic or industry experience working with medical devices
Salary: $105,000 - $195,000 USD
Type: Full-time
Benefits: Full-time employees are eligible for excellent medical, dental, and vision insurance through a PPO plan, paid holidays,…

Ultima Genomics

Senior Quality Engineer, Reagents Fremont
Skills & Focus: quality gaps, ISO 13485, batch records, work instructions, SOPs, testing, calibration, non-conforming material, investigations, raw materials
About the Company: A rapidly growing company developing groundbreaking genomics technologies focused on scaling genomic information to advance biology and human health.
Experience: 5+ years in reagents or consumables quality
Salary: $100,000 - $120,000
Benefits: Medical, dental, vision, life, disability insurance; 401(k); flexible spending & health savings accounts; paid holidays…

Johnson & Johnson

Principal R&D Technician (Claims Development) Fremont
Skills & Focus: R&D Operations, Product Development Testing, catheter testing, design and process, test methods, Good Manufacturing Practices, Good Documentation Practices, product assembly, clinical trials, test equipment
About the Company: At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented,…
Experience: 10 years as R&D Technician or 8 years with an Associate’s degree
Salary: $30.67 - $49.26 per hour
Type: Fully Onsite
Benefits: Medical, dental, vision, life insurance, short- and long-term disability.

Stryker

Senior Engineer, Design Quality Fremont
Skills & Focus: product design, qualification plans, product testing, failure analysis, technical reports, risk management, statistical analysis, design control, Medical Device, Neurovascular
Experience: 2+ years
Salary: $100,400.00 - $160,800.00
Type: Full-time
Benefits: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insur…

Gti (Green Thumb Industries)

Quality Assurance Manager Fremont
Skills & Focus: quality assurance, QA/QC, GMP, HACCP, QMS, root cause analysis, product quality, compliance, regulatory, team leadership
About the Company: GTI is a company involved in the cannabis industry, focused on producing and distributing cannabis products.
Experience: Minimum 5 years of QA/QC experience in a regulated production organization
Salary: $95,000 - $120,000 USD

Johnson & Johnson

Principal R&D Proj Mgr, Early Stage - Shockwave Fremont
Skills & Focus: Project Management, R&D, Medical Device, Product Development, Clinical Studies, Risk Management, Quality System Regulations, Interpersonal Skills, Communication Skills, Leadership
About the Company: Johnson & Johnson is a world leader in healthcare innovation that strives to build a healthier world through the prevention, treatment, and cure of complex dis…
Experience: 10+ years in Medical Device; 5+ years in project management
Salary: $121,000-$194,350
Type: Hybrid
Benefits: Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, group legal insu…

Baxter

Manager Quality Assurance Hayward
Skills & Focus: Quality Assurance, Healthcare, Innovation, Engineering, Manufacturing, Diversity, Employee Development, Patient Care, Compliance, Teamwork
About the Company: Baxter is a global medtech company that innovates and manufactures healthcare products, focusing on saving and sustaining lives.
Type: Full-time
Benefits: Comprehensive benefits options reflecting the value placed on employees.

Arsenal Biosciences Inc.

Director, Process Engineering Hayward
Skills & Focus: Process Engineering, cell therapy, technology transfer, process comparability studies, qualification activities, manufacturing investigations, process performance, raw material qualification, process characterization, BLA readiness
About the Company: Arsenal Biosciences Inc. is a clinical-stage programmable cell therapy company engineering advanced CAR T-cell therapies for solid tumors.
Experience: Experienced
Type: Full-time

Arcus Biosciences

Manager, Safety Quality and Compliance Contractor (Office or Remote) Hayward
Skills & Focus: Safety, Quality, Compliance, Pharmacovigilance, PV, Regulatory, Audits, Inspection, Deviations, CROs

Baxter

Lead Microbiologist, QC Lab Hayward
Skills & Focus: Microbiology, Quality Control, Medical Devices, Healthcare, Innovation, Manufacturing, Patient Care, Data Management, Clinical Education, Regulatory Compliance
About the Company: Baxter is a leading manufacturer of medical devices and solutions, committed to innovating and producing high-quality products to improve healthcare outcomes.
Type: Full time
Benefits: Our comprehensive benefits options reflect the value we place in our employees.

Arsenal Biosciences Inc.

Director of GMP Procurement and Planning Hayward
Skills & Focus: GMP, Procurement, Planning, CAR T-cell therapies, solid tumors, contract negotiation, material planning, ordering, clinical programs, cell therapy
About the Company: Arsenal Biosciences Inc. is a clinical-stage programmable cell therapy company engineering advanced CAR T-cell therapies for solid tumors.
Type: Full-time
Master Maintenance Mechanic Hayward
Skills & Focus: maintenance, mechanic, preventative maintenance, quality standards, GMP conditions, equipment, work orders, project tasks, clinical-stage, cell therapy
About the Company: Arsenal Biosciences Inc. is a clinical-stage programmable cell therapy company engineering advanced CAR T-cell therapies for solid tumors.
Type: Contract

Baxter

Quality Technician Hayward
Skills & Focus: Quality, Technician, Microbiology, Laboratory, Inspection, Quality Assurance, Quality Control, Medical Devices, Healthcare, Regulatory
About the Company: Baxter International is a global healthcare company that focuses on developing and providing innovative medical devices and solutions.
Type: Full-time
Analyst II, Quality Compliance Hayward
Skills & Focus: Quality Management System, Compliance, Internal audits, Regulatory standards, ISO 13485, Change Control, Document Control, SOPs, Quality training, CAPA
About the Company: Baxter is a global medical technology company that is deeply connected by its mission of saving and sustaining lives. It has pioneered significant medical inno…
Experience: 3+ years
Type: Full-time
Benefits: Comprehensive compensation and benefits packages, including medical and dental coverage, insurance for life, short-term…

Billiontoone

Quality Engineer, Oncology Menlo Park
Skills & Focus: quality engineer, molecular diagnostics, LDT, bioinformatics, process improvements, root cause analysis, CAPA, regulatory requirements, continuous improvement, statistical analysis
About the Company: BillionToOne is a next-generation molecular diagnostics company dedicated to developing powerful and accurate diagnostic tests that are accessible to all. Our …
Experience: Minimum of 5 years of experience within the LDT industry
Salary: $167,805 per year
Type: Full-time
Benefits: Multiple medical benefit options; employee premiums paid 100% of select plans, dependents covered at 80%; extremely gen…

Johnson & Johnson

Principal R&D Technician (Claims Development) Milpitas
Skills & Focus: R&D Operations, Product Development Testing, catheter testing, design and process, test methods, Good Manufacturing Practices, Good Documentation Practices, product assembly, clinical trials, test equipment
About the Company: At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented,…
Experience: 10 years as R&D Technician or 8 years with an Associate’s degree
Salary: $30.67 - $49.26 per hour
Type: Fully Onsite
Benefits: Medical, dental, vision, life insurance, short- and long-term disability.
Principal R&D Engineer (Balloon Tech) - Shockwave Milpitas
Skills & Focus: R&D, Biomedical Engineering, Product Development, Innovation, Medical Devices, Design Control, Technology Development, Prototyping, Polymer Science, Clinical Needs
About the Company: At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented,…
Experience: 10 years experience in the medical device industry or 8 years with a Master's Degree
Type: Full-time

Aditum Bio

VP of CMC Oakland
Skills & Focus: CMC operations, drug substance, drug product manufacturing, cGMP, Phase 3 registration, regulatory submissions, Contract Manufacturing Organizations, supply chain, clinical studies, FDA regulations
About the Company: At Aditum Bio our mission is to provide access to medicines to patients in need. Co-founded by industry veterans Joe Jimenez, former CEO of Novartis and Mark F…
Experience: Minimum 10 years in pharmaceutical/biotechnology industry
Salary: $345,000 to $375,000 plus target bonus, equity compensation
Type: Full-time
Benefits: Medical, dental, vision, disability, life, 401k plan with match, flexible/non-accrued PTO plus 12 paid holidays, sick l…
Associate Director / Director R&D Quality Assurance Oakland
Skills & Focus: GxP, GCP, GLP, Quality Assurance, Regulatory Compliance, Audit, CAPA, RCA, Quality Management System, Clinical Research
About the Company: At Aditum Bio our mission is to provide access to medicines to patients in need. Co-founded by industry veterans Joe Jimenez, former CEO of Novartis and Mark F…
Experience: At least 10 years within pharmaceutical and/or biotech industry
Salary: $175,000 to $215,000 depending on experience plus bonus, equity, and benefits
Type: Full-time
Benefits: Medical, dental, vision, disability, life, 401k plan with match, flexible PTO, paid holidays, sick leave, parental leave

Delfi Diagnostics, Inc.

Staff Systems Engineer Palo Alto
Skills & Focus: NGS-based diagnostics, early cancer detection, cross-functional team, user needs, product requirements, specifications, risks, verification, validation activities, FDA submissions
About the Company: DELFI Diagnostics is developing next-generation, blood-based tests that are reliable, accessible and deliver a new way to help detect cancer. Employing advance…
Quality Systems Manager Palo Alto
Skills & Focus: Quality Management System, compliance, regulatory requirements, continuous improvements, IVD activities, oversight, health outcomes, machine learning, blood-based tests, fragmentomics
About the Company: DELFI Diagnostics is developing next-generation, blood-based tests that are reliable, accessible and deliver a new way to help detect cancer. Employing advance…

Ascendis Pharma

Associate Director, Global Pharmacovigilance Operations Palo Alto
Skills & Focus: Pharmacovigilance, Drug Safety, Individual Case Safety Reports (ICSRs), FDA safety regulations, ICH Guidelines, Adverse events, Study Management Teams (SMTs), Safety Management Plan (SMPs), Training documents (SOPs), Market Research and Patient Support programs (MAPs)
About the Company: Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. We are advancing programs…
Experience: Minimum of 8 years recent experience in Pharmacovigilance required; relevant pharmaceutical industry experience in drug safety required.
Benefits: 401(k) plan with company match; Medical, dental, and vision plans; Company-offered Life and Accidental Death & Dismembe…

Teleflex

Sr. R&D Engineer Pleasanton
Skills & Focus: mechanical design, product development, medical device, ISO 13485, MDD, FDA QSR, clinical applications, design transfer, quality management systems, medical technologies
About the Company: A global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become …
Experience: Typically requires a minimum of 8 years of related experience with a bachelor's degree or equivalent, or 6 years with a master's degree, or 3 years with a PhD.

Guardant Health

Senior Quality Engineer Redwood City
Skills & Focus: Quality Management, FDA regulations, ISO 13485, Process Controls, Risk Management, Validation, Continual Improvement, Internal Audits, Statistical Process Control, Change Control
About the Company: Guardant Health specializes in precision oncology and offers innovative solutions for cancer detection and treatment.

Arcellx

Quality Control Manager Redwood City
Skills & Focus: QC activities, analytical data, method qualification, GMP, regulatory submissions, statistical analysis, trend analysis, SOPs, cross functional teams, cGMP/ICH/FDA regulations
About the Company: Arcellx is a public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other…
Experience: At least 5+ years (with PhD) or 8+ years (with BS) of relevant experience in AD/QC
Salary: $140,000 - $165,000 per year
Type: Full-time
Benefits: 100% coverage for medical, dental and vision for team members and dependents, unlimited vacation, a 3-day weekend every…

Adverum Biotechnologies, Inc.

Director, QA Validation Redwood City
Skills & Focus: validation, quality assurance, regulatory requirements, biological sciences, pharmaceutical industry, cross-functional leadership, regulatory audits, GMP compliance, continuous improvement, risk management
About the Company: Adverum Biotechnologies, Inc. is a mission-driven clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocu…
Experience: 13+ years of progressive responsibility in validation experience in the pharmaceutical industry
Salary: $205,000 - $215,000
Type: Full-time
Benefits: Employees in this position are eligible to participate in the applicable Company equity incentive award plan. The amoun…

Carbon, Inc.

Senior Chemical Regulatory Specialist Redwood City
Skills & Focus: Regulatory Compliance, Chemical Regulations, REACH, TSCA, Product Development, Material Registration, Regulatory Documentation, Supply Chain, Hazard Classification, GHS
About the Company: Carbon, our mission goes beyond 3D printing. We are enabling creators everywhere to make what the world needs, right now. Our company is built on the idea that…
Experience: 5-10 years
Salary: $115,200 - $172,800
Type: Full-time

Noah Medical

R&D Manager, I&A San Carlos
Skills & Focus: robotics, medical device, design controls, risk management, NPI, FDA quality system regulations, technical leadership, project management, collaborative leadership, creative problem solving
About the Company: Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple…
Experience: 8+ years of experience in medical device, 3+ years leading technical teams
Salary: $164,400 - $210,000
Type: Full-time
Benefits: Competitive Salary, Comprehensive health insurance including Medical, Dental and Vision, Equity & Bonus Program, 12+ pa…
Senior R&D Engineer, I&A San Carlos
Skills & Focus: medical devices, design improvements, root cause analysis, Solidworks, project management, cross-functional collaboration, prototype devices, test protocols, risk controls, brainstorming sessions
About the Company: Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple…
Experience: Minimum 3 years of direct experience in medical devices
Salary: 120600 - 160000 USD
Type: Full-time
Benefits: Competitive Salary; Comprehensive health insurance; Equity & Bonus Program; Life Insurance; Mental health support; 12+ …
Staff Systems Engineer San Carlos
Skills & Focus: systems engineering, robotic systems, risk management, regulatory compliance, verification, validation, system architecture, requirements management, medical devices, collaboration
About the Company: Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple…
Experience: 10+ years of experience
Salary: $158,400 - $200,000 USD
Type: Full-time
Benefits: Competitive Salary, Comprehensive health insurance, Equity & Bonus Program, Life and Disability insurance, Paid time of…

Outset Medical

Senior Systems Engineer San Jose
Skills & Focus: systems engineering, medical devices, verification, validation, requirements management, risk management, cross-functional teams, problem-solving, leadership, communication skills
About the Company: A trailblazing medical device company focused on revolutionizing dialysis technology to improve patient care.
Experience: 5+ years of experience in systems engineering
Salary: $125,000 - $169,000 USD
Type: Full-time

Super Micro Computer

Quality Systems Analyst San Jose
Skills & Focus: Quality Management System (QMS), Environmental Management System (EMS), Information Security Management System (ISMS), ISO 9001, ISO 13485, ISO 14001, ISO 27001, internal audits, Corrective and Preventive Actions (CAPA), Documentation Control
About the Company: Supermicro® is a Top Tier provider of advanced server, storage, and networking solutions for Data Center, Cloud Computing, Enterprise IT, Hadoop/Big Data, Hype…
Experience: Minimum 2 years of relevant experience in quality system
Salary: $68,640 - $74,000
Sr. Director, Global Trade Compliance San Jose
Skills & Focus: global trade compliance, import/export laws, trade compliance team, export control compliance, customs regulations, sanctions, ECCN, HTS codes, semiconductor trade restrictions, advanced GPU products
About the Company: Supermicro® is a Top Tier provider of advanced server, storage, and networking solutions for Data Center, Cloud Computing, Enterprise IT, Hadoop/ Big Data, Hyp…
Experience: 10+ years of experience in import and export global trade compliance preferred.
Salary: $210,000 - $250,000
Benefits: In addition to a comprehensive benefits package, candidates may be eligible for other forms of compensation, such as pa…

Visby Medical

Quality Engineer I San Jose
Skills & Focus: Quality Assurance, medical device, 21 CFR 820, ISO 13485, CAPA investigations, statistical tools, process improvements, GMP compliance, technical reports, ERP/MRP systems
About the Company: Visby Medical is an ambitious, well-funded late-stage biotech startup. Driven by a belief that infectious disease diagnosis should be quick, accurate, and acce…
Experience: Minimum of 2 years of experience in Quality Assurance in the medical device field.
Salary: $62,400 - $80,000 a year
Type: Full-time
Benefits: Visby offers highly competitive health insurance through Cigna or Kaiser, including a company-funded HSA option, flexib…

Sanmina Corporation

Quality Engineer San Jose
Skills & Focus: quality assurance, inspection, testing, lean, six sigma, ISO13485, data analysis, medical device, manufacturing, compliance
About the Company: Sanmina Corporation (Nasdaq: SANM) is a leading integrated manufacturing solutions provider serving the fastest-growing segments of the global Electronics Manu…
Experience: 5+ years of experience as a Quality Engineer
Salary: $95,000 - $103,000
Type: Full-time
Benefits: health insurance coverage, life and disability insurance, savings plan, Company paid holidays and paid time off (PTO), …

Intuitive Surgical

Regulatory Affairs Specialist, NPD San Jose
Skills & Focus: regulatory, 510(k), medical devices, technical documentation, product development, submissions, design controls, biocompatibility testing, communication skills, project management
About the Company: At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, w…
Experience: Minimum 3 years relevant experience working in a medical device company
Salary: $114,800 - $165,200 USD
Type: Full-time
Benefits: Market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity.

Super Micro Computer

Sr. Quality Systems Analyst San Jose
Skills & Focus: quality management, environmental management, ISO standards, auditing, compliance, continuous improvement, document management, training, cross-functional collaboration, data analysis
About the Company: Supermicro® is a Top Tier provider of advanced server, storage, and networking solutions for Data Center, Cloud Computing, Enterprise IT, Hadoop/ Big Data, Hyp…
Experience: Minimum 8 years (or a Master’s degree with minimum 6 years) of relevant experience in quality, environmental and other management systems.
Salary: $95,000 - $115,000
Benefits: Comprehensive benefits package; eligibility for bonus and equity award programs.

Sanmina Corporation

Quality Engineer San Jose
Skills & Focus: Quality Assurance, Inspection, Raw Materials, Finished Products, Process Control, ISO, GMP, Lean/6 Sigma, Data Analysis, Manufacturing
About the Company: A leading integrated manufacturing solutions provider serving various segments of the global Electronics Manufacturing Services (EMS) market, including communi…
Experience: 5+ years as a Quality Engineer
Salary: $95,000 - $103,000
Type: Full-time
Benefits: Health insurance coverage, life and disability insurance, savings plan, paid holidays, PTO, potential stock awards, bon…

Biomérieux

Regulatory and Quality Compliance Expert San Jose
Skills & Focus: regulatory compliance, quality procedures, vigilance reporting, adverse event reporting, medical device, project management, cross-functional team, SOPs, audit, continuous improvement
Experience: 7+ years in regulatory affairs or equivalent regulated industry employment position, medical device/IVD industry preferred

Visby Medical

Staff Mechanical Engineer San Jose
Skills & Focus: medical devices, design, development, product function, solidworks, precision injection molded components, fluid handling, design control process, class 2 medical device, test method development
About the Company: Visby Medical is an ambitious, well-funded late-stage biotech startup. Driven by a belief that infectious disease diagnosis should be quick, accurate, and acce…
Experience: Greater than 7 years of experience in the development of medical devices.
Salary: $175,000 - $200,000
Type: Full-time
Benefits: Visby offers highly competitive health insurance through Cigna or Kaiser, including a company-funded HSA option. We als…

Biomérieux

Sr. Product Development Scientist San Jose
Skills & Focus: Product Development, Medical Device, Microbiology, Antimicrobial Susceptibility Testing, Chemistry, Data Analysis, Experimental Design, Regulatory Compliance, Quality Assurance, Biotechnology
About the Company: bioMérieux is a pioneering force in the medical microbiology device industry. Our cutting-edge technologies have been transforming healthcare and improving pat…
Experience: 1+ years with PhD, 4+ years with MS, or 6+ years with BS in relevant field.
Salary: $108,400 – 133,900
Type: Full-time
Benefits: A choice of medical, dental, and vision plans, life and accidental death insurance, disability insurance, retirement pl…
Sr. Manager, Software Development San Jose
Skills & Focus: Software Development, Project Management, Medical Device, Agile methodologies, C#, Python, Documentation, Collaboration, Risk Management, Continuous Improvement
About the Company: bioMérieux is a pioneering force in the medical microbiology device industry, transforming healthcare and improving patient outcomes with cutting-edge technolo…
Experience: 10 years in Software Development or 8 years with a Master’s Degree, plus 5+ years of Managerial experience and 5+ years of Medical Device experience.
Salary: $162,400 – 194,900
Type: Full-time
Benefits: Health and wellness programs, company-provided life insurance, retirement plans, paid parental leave, and other competi…

Visby Medical

Staff Systems Engineer San Jose
Skills & Focus: Systems Engineering, PCR, diagnostics, device integration, functional testing, design requirements, test methods, Verification and Validation, cross-functional teams, FDA regulations
About the Company: Visby Medical is an ambitious, well-funded late-stage biotech startup. Driven by a belief that infectious disease diagnosis should be quick, accurate, and acce…
Experience: At least 5 years of development experience in a highly regulated industry (medical, aerospace, etc.)
Salary: $175,000 - $200,000 a year
Type: Full-time
Benefits: Highly competitive health insurance through Cigna or Kaiser, including a company-funded HSA option. Flexible paid time …

Mendaera, Inc.

Staff NPI Engineer San Mateo
Skills & Focus: design transfer, manufacturing processes, improvement, DFM, DFA, quality, root cause analysis, pFMEA, medical device, cGMP
About the Company: Mendaera is developing technology that will enable all healthcare providers to do more for their patients. Our platform combines real-time imaging, robotics, a…
Experience: 8 years experience in industry or equivalent
Salary: $168,000-$211,000

Ideaya Biosciences

Sr Director, GMP & CSV QA South San Francisco
Skills & Focus: Good Manufacturing Practices, Computer System Validation, Quality Systems, Deviation, Corrective Action, Preventive Action, Change Control, Batch Release Systems, regulatory requirements, product quality
About the Company: IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage precision medicine oncology company committed to the discovery, development, and commercializatio…

Alumis Inc.

Vice President, Quality Operations South San Francisco
Skills & Focus: GMPQA, GLP, Quality Assurance, manufacturing, regulatory compliance, process development, quality oversight, team leadership, small molecule manufacturing, collaborative culture
About the Company: Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases.
Experience: Minimum 15 years of GMP Quality Assurance experience, 10+ years of demonstrated experience in leading and managing teams.
Type: Full-time
Benefits: Health insurance premiums paid at 90% for employee, 80% for dependents, Free access to Genentech Bus & Ferry Share prog…