Last updated: 2025-05-22

66 Quality Assurance And Engineering jobs in San Francisco.

Hiring now: Dir Regulatory Document Q @ Exelixis, Medical Education Program @ Penumbra, Quality Engr @ Penumbrain, Quality Engr Ii @ Penumbra, Medical Devices Quality M @ Meta, Medical Devices Quality M @ Facebook R, Sr Analyst Quality Contro @ Alamar Bio, Sr Quality Engr Reagents @ Ultima Gen, Sr Quality Mgr @ Sanmina, Principal Rd Tech Claims @ Johnson Jo.Explore more at at kaamvaam.com

🔥 Skills

ISO 13485 (9) Regulatory Compliance (9) SOPs (7) Quality Management System (7) Continuous Improvement (7) quality assurance (7) project management (6) Compliance (6) Medical Devices (6) Quality Assurance (6)

📍 Locations

Alameda (9) Fremont (8) Novato (8) Redwood City (7) San Francisco (7) Hayward (6) San Carlos (4) Milpitas (3) Pleasanton (3) Burlingame (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

Medical Education Program Associate Alameda
Skills & Focus: Medical Education, Event Planning, Compliance, Logistics, Communication Skills, Microsoft Office, Quality Management System, Travel Coordination, Interpersonal Skills, Medical Device
Experience: 1+ year of relevant experience
Salary: $70,000 - $90,000
Type: Hybrid
Benefits: competitive compensation package plus a benefits and equity program

Penumbrainc

Quality Engineer Alameda
Skills & Focus: Quality Engineering, Medical Devices, Testing Methodology, Inspection Documentation, Continuous Improvement, Supplier Activities, Engineering Change Orders, QC Process, Quality Management System, Regulations
Experience: 3+ years of quality engineering or relevant experience
Salary: $109,000/year to $152,000/year

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…

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…

Alamar Biosciences

Sr. Analyst, Quality Control Fremont
Skills & Focus: Quality Control, proteomics, testing, ISO 13485, GMP, data analysis, assay troubleshooting, specification optimization, nonconformance resolution, process documentation
About the Company: At Alamar Biosciences, we’re on a mission to transform the field of proteomics for the early detection of cancer and other diseases. We are creating the world’…
Experience: 4+ years in Quality Control or similar environment
Salary: $90,000 - $105,000 + bonus + equity + benefits
Type: Full-time

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…

Sanmina Corporation

Sr. Quality Manager Fremont
Skills & Focus: Quality Management System, Continuous Improvement, Quality Engineering, Supplier Quality Management, ISO 9001:2015, AS9100:2016, Lean Manufacturing, Six Sigma, NPI, Regulatory 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: Minimum of 12 years of experience in quality engineering or related area in a manufacturing environment
Salary: $140,000 - $180,000
Type: Full-time
Benefits: Health insurance coverage, life and disability insurance, savings plan, Company paid holidays and paid time off (PTO), …

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.

Alamar Biosciences, Inc.

Lead Manufacturing Specialist - Lyophilization Fremont
Skills & Focus: Manufacturing, Lyophilization, cGMP, ISO 13485, Production Planning, Technical Support, Continuous Improvement, Aseptic Techniques, Standard Operating Procedures, Troubleshooting
About the Company: At Alamar Biosciences, we’re on a mission to transform the field of proteomics for the early detection of cancer and other diseases. We are creating the world’…
Experience: 7+ years’ experience in pharmaceutical or biotechnology manufacturing or equivalent experience, with 4+ years of hands on experience in lyophilization
Salary: $110,000 - $130,000
Type: Full-time
Benefits: Bonus + equity + benefits

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…

Zoox

Quality Systems Manager Fremont
Skills & Focus: Quality Management System, QMS, Quality Policy, best practices, customer expectations, A.I., robotics, hardware development, key systems, creativity
About the Company: At Zoox, you will collaborate with a team of world-class engineers with diverse backgrounds in areas such as A.I. and robotics.
Type: Full-time

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…

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…

Bio-Rad Laboratories, Inc.

Engineer, Staff Hercules
Skills & Focus: systems engineering, clinical diagnostics, product development, engineering principles, risk management, human factors, design for manufacturability, quality, reliability, adoption of DfX
About the Company: Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we…
Experience: 8+ years
Salary: $133,900 to $184,200
Type: Hybrid
Benefits: We’re proud to offer a variety of options, including competitive medical plans for you and your family, free HSA funds,…

Lawrence Livermore National Laboratory

Quality Assurance Engineer Livermore
Skills & Focus: Quality Assurance, Strategic Deterrence, Nuclear Facilities, Inspections, Audits, Assessments, Procedures, Regulators, Continuous Improvement, Safety
About the Company: A premier research institution focused on science and technology for national security.

Corcept

Associate Director, Clinical Quality Assurance Menlo Park
Skills & Focus: data management, clinical trials, CDISC compliance, EDC systems, SOPs, data quality, project management, pharmacovigilance, biomedical data, data visualization
About the Company: Corcept is committed to improving patient lives through the discovery and development of drugs that address serious unmet medical needs related to excess corti…
Experience: 12+ years experience in clinical trial industry (med device, pharma or biotech), 10+ years experience in data management in clinical trial industry.

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

Sgs

Senior Compliance Engineer Milpitas
Skills & Focus: Compliance, Testing, Test Plan, Test Setup, Monitoring, Quality Procedures, Design, Accreditations, Laboratory Equipment, Standards

Heartflow

Imaging Analyst - 3D Computer Skills Mountain View
Skills & Focus: 3D modeling, CT imaging, medical imaging, visual inspection, compliance, quality assurance, healthcare, computer skills, technical program, regulated environment
About the Company: Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edg…
Experience: Previous experience working in a regulated industry preferred.
Salary: $27.72-$28.72 per hour
Type: Full-time
Benefits: Bonus program, comprehensive health care coverage, health savings account, disability and life insurance, flex spending…

Biomarin Pharmaceutical Inc.

Sr. Associate, Manufacturing Novato
Skills & Focus: bioprocessing, cGMP compliance, biotechnology, manufacturing, cell culture, purification, standard operating procedures, good documentation practices, teamwork, quality assurance
About the Company: BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic di…
Experience: 2 years of industry experience.
Type: Full-time
Sr. Associate, Manufacturing Novato
Skills & Focus: bioprocess equipment, cGMP, standard operating procedures, compliance, biotech manufacturing, cell culture, protein purification, data capturing, team environment, quality assurance
About the Company: BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic di…
Experience: 2 years of industry experience
Type: Full-time

Biomarin

Director, Engineering and Facilities Operations Novato
Skills & Focus: Facilities Management, Engineering Operations, GMP Compliance, Utilities Systems, Process Equipment, Asset Lifecycle, Continuous Improvement, Budget Management, Leadership, Biotech Industry
About the Company: BioMarin is a global biotechnology company focused on developing and commercializing innovative biopharmaceuticals for serious and life-threatening rare diseas…
Sr. Associate, Manufacturing Novato
Skills & Focus: bioprocess, cGMP, SOPs, biotech manufacturing, cell culture, protein purification, buffer operations, compliance, team environment, quality assurance
About the Company: BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic di…
Experience: 2 years of industry experience
Salary: $59,400 to $81,730
Type: Full-time
Benefits: company-sponsored medical, dental, vision, and life insurance plans, discretionary annual bonus, discretionary stock-ba…

Biomarin Pharmaceutical Inc.

Director, Engineering and Facilities Operations Novato
Skills & Focus: Facilities, Engineering, Operations, GMP, Biotech, Utilities, Facilities Management, Automation, Continuous Improvement, Leadership
About the Company: BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future o…
Experience: Minimum 10 years of experience in biotech industry with GMP/GCP compliance, extensive experience in building management systems, process control, and data acquisition systems.

Biomarin

Associate, QA Frontline (TEMPORARY) Novato
Skills & Focus: QA oversight, cGMP compliance, batch records, quality assurance, documentation, root cause analysis, manufacturing support, investigation, change control, analytical skills
About the Company: BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future o…
Experience: Prior batch record execution or review experience; working knowledge of cGMPs.
Type: Temporary
Benefits: A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition…

Biomarin Pharmaceutical Inc.

Director, Engineering and Facilities Operations Novato
Skills & Focus: Facilities, Engineering, Operations, biotech, GMP, utilities, maintenance, automation, cGMP, quality
About the Company: BioMarin is a global biotechnology company that develops medicines for serious and life-threatening rare genetic diseases, focusing on unique genetic condition…

Biomarin

Sr. Supervisor, Manufacturing (Day Shift) Novato
Skills & Focus: manufacturing, leadership, quality assurance, quality control, process automation, troubleshooting, documentation, team management, regulatory standards, scientific thinking
About the Company: BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future o…
Experience: 4-6 years Manufacturing Experience, 2+ years Leading a team
Salary: $95,000 to $142,600 per year
Type: Full-time
Benefits: a discretionary bonus, long-term incentive units, full range of medical, financial, and/or other benefits

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…

Teleflex

Sr. R&D Engineer (Mechatronics) Pleasanton
Skills & Focus: Mechatronics, Electromechanical systems, Software development, Robotics, Medical devices, Testing, Collaboration, Clinical application, Product design, Regulatory compliance
About the Company: Teleflex is a global provider of medical technologies driven by a purpose to improve the health and quality of people's lives.
Experience: Typically requires a minimum of 8 years of related experience.
Sr. R&D Engineer (Mechatronics) Pleasanton
Skills & Focus: Mechatronics, Electromechanical systems, Robotics, Software development, Medical devices, Product design, System architecture, Clinical procedures, Quality management, Automation
About the Company: As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives.
Experience: Typically requires a minimum of 8 years of related experience with a bachelor’s degree in engineering or a related major.
Salary: $125,000-160,000
Type: Full-time
Benefits: medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings pl…
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.

Coherus Biosciences

Director/Senior Director, CMC Regulatory Affairs Redwood City
Skills & Focus: Regulatory Affairs, CMC strategy, licensure, submission planning, regulatory requirements, risk identification, authoring regulatory documents, collaborative work, biologics drug development, FDA submissions
Experience: Minimum 8 years of relevant experience in CMC Regulatory Affairs
Salary: $185,000 to $250,000
Type: Full-time

Adverum Biotechnologies, Inc.

Director Process Development (Late Stage Development) Redwood City
Skills & Focus: Process Development, Biologics, Gene Therapy, AAV, CQA, Process Scale-up, CDMO, Regulatory Compliance, Bioprocess, CQA
About the Company: A mission-driven clinical-stage company specializing in gene therapy for ocular diseases, aiming to establish gene therapy as a new standard of care and develo…
Experience: 10+ years (MS); 15+ years (BS) in bioprocess development
Salary: $207,675 - $222,359 USD annually
Type: Full-time
Benefits: Company equity plans, medical/dental/vision insurance, 401k, STD/LTD, life and accident insurance, paid time off

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…

Retro

Director of Regulatory Science Redwood City
Skills & Focus: regulatory science, FDA approval, therapeutics, cellular reprogramming, manufacturing, regulatory bodies, clinical stage, project management, communication, multitasking
About the Company: Retro develops therapies for diseases driven by the biology of aging, focusing on cellular reprogramming and autophagy.

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…

Redwood Materials

Staff Product Regulatory & Compliance Engineer San Francisco
Skills & Focus: Regulatory Compliance, Energy Storage, Product Certification, New Product Introduction (NPI), Safety Standards, Stakeholder Collaboration, Risk Management, Certification Programs, Standards Organizations, Sustainability
About the Company: Redwood Materials was founded in 2017 to create a circular supply chain for electric vehicles and clean energy products, making them more sustainable and drivi…
Experience: Minimum of 7+ years of experience in regulatory compliance, product certification, or NPI, preferably in energy storage or a related industry.
Salary: $129,000 – $205,000 USD
Type: Full-time

Nurix Therapeutics

Senior Manager/Associate Director Clinical Quality Assurance Auditor San Francisco
Skills & Focus: Quality Assurance, Auditing, Clinical Trials, Regulatory Compliance, GCP, SOPs, Risk Management, Clinical Operations, Vendor Management, Inspection Readiness
About the Company: Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation m…
Experience: 5-8 years GCP Quality Assurance auditing experience

Pendulum

Manager, Supplier Quality San Francisco
Skills & Focus: Supplier Quality, Quality Management Program, Cross-functional Team, Risk Management, Performance Monitoring, Continuous Improvement, Regulatory Requirements, Probiotics, Therapeutic Offerings, Relationship Management
About the Company: Pendulum® is leading a revolution that is occurring around the world to improve physical and mental health by first understanding, then restoring and enhancing…
Type: Full-time

Bridgebio Pharma

Sr. Director, Clinical Data Management San Francisco
Skills & Focus: Data Management, Clinical Research, Clinical Trials, Regulatory Compliance, EDC Systems, NDA Submissions, Vendor Oversight, Biostatistics, Clinical Data Quality, Statistical Programming
About the Company: BridgeBio Pharma is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines for genetic diseases and cancers.
Experience: Minimum 15 years in Data Management with 5-7 years in a managerial role.
Salary: $245,000 - $280,000 USD
Type: Full-time
Benefits: Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retir…

Abbvie

Senior Manager, Global Regulatory Strategy US & Canada (Hybrid Onsite) San Francisco
Skills & Focus: regulatory strategy, FDA, regulatory submissions, pharmaceutical, regulatory activities, regulatory agency, US and Canada, compliance, cross-functional, regulatory knowledge
About the Company: AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tom…
Experience: 6 years Regulatory, R&D, or Industry-related experience
Salary: $121,000 - $230,000
Type: Full-time

Bridgebio Pharma

Manager, Pharmaceutical Packaging San Francisco
Skills & Focus: pharmaceutical labeling, cGMP compliance, drug product packaging, FDA regulations, operational documentation, labeling process, change control, regulatory filing, collaboration with CMOs, quality systems
About the Company: BridgeBio Pharma is a biopharmaceutical company focused on discovering, creating, testing, and delivering transformative medicines for genetic diseases and can…
Experience: Minimum of 7 years of relevant pharmaceutical industry experience
Salary: $140,000 - $178,000 USD
Type: Full-time
Benefits: Robust and market-competitive compensation & benefits package including health, welfare & retirement programs, flexible…

Cai

Validation Process Engineer San Francisco
Skills & Focus: Validation, Commissioning, Qualification, Document Development, Regulated Industry, Technical Problem-Solving, Project Management, Microsoft Word, Microsoft Excel, ISPE Baseline Guide 5
About the Company: CAI is a 100% employee-owned company established in 1996 that has grown to more than 800 people worldwide. We provide commissioning, qualification, validation,…
Experience: 4-16 years’ experience performing commissioning and/or qualification activities in a regulated industry
Type: Full-time
Benefits: competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per…

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