65 Quality Assurance And Engineering jobs in San Jose.

Hiring now: Quality Engr I @ Penumbra, Dir Regulatory Document Q @ Exelixis, Quality Engr @ Penumbrain, Research And Development @ Penumbra, Enablement Lead Prod Qual @ Meta, Medical Devices Quality M @ Facebook R, Sr Analyst Quality Contro @ Alamar Bio, Vice President Cell Thera @ Novo Nordi, Lead Manufacturing Spec L @ Alamar Bio, Staff Hardware Engr Quali @ Google.Explore more at jobswithgpt.com.

🔥 Skills

ISO 13485 (10) Medical Devices (9) Risk Management (9) Quality Management System (8) GMP (8) Quality Assurance (8) Quality Engineering (7) project management (7) cell therapy (7) Regulatory Compliance (6)

đź“Ť Locations

Alameda (12) Fremont (12) Redwood City (9) Hayward (8) Milpitas (5) Mountain View (4) Burlingame (3) Palo Alto (3) Livermore (2) Menlo Park (2)
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Penumbra

Quality Engineer I Alameda
Skills & Focus: Quality Engineering, Medical Devices, Design Control, Biocompatibility, Sterilization, Process Improvement, Root-Cause Analysis, Quality Management System, Manufacturing Operations, Product Launch
Experience: 1+ years of experience in a manufacturing or laboratory environment strongly preferred
Salary: $80,000 to $105,000

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…
Senior Clinical Supplies Manager Alameda
Skills & Focus: clinical supply management, labeling, packaging, distribution, IRT, clinical trials, project management, GMP, GCP, GLP
About the Company: Exelixis focuses on the development of innovative therapies for cancer.
Experience: Minimum of nine years of related experience; or, a minimum of seven years with MS/MA degree.
Salary: $138,000 - $196,000
Type: Full-time
Benefits: Comprehensive employee benefits package including 401k, medical, dental, vision coverage, life and disability insurance…
Senior Director, Clinical Compliance (Biotechnology, Oncology, GCP) Alameda
Skills & Focus: Clinical Compliance, Risk Management, Quality Assurance, Biotechnology, Clinical Research, ICH GCP, Process Improvement, Leadership, Regulatory Compliance, Issue Management
About the Company: Exelixis is a biotechnology company focused on the development of small molecule therapies for the treatment of cancer.
Experience: Minimum of 15 years of related experience in the biotech/pharmaceutical industry.
Salary: $245,500 - $349,000
Type: Full-time
Benefits: Comprehensive employee benefits package including a 401k plan, group medical, dental and vision coverage, life and disa…

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, Inc.

Research and Development Engineer I Alameda
Skills & Focus: Research and Development, engineering designs, product testing, engineering test protocols, prototype assembly, troubleshooting, Quality Management System, regulations and standards, medical device industry, analytical skills
Experience: Bachelor’s degree in Engineering, Physical Sciences or related technical field or equivalent combination of education and experience.
Salary: $80,000 to $105,000

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

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.

Manufacturing Engineering Manager Alameda
Skills & Focus: manufacturing engineering, quality system, cross-functional teams, medical devices, GMP regulations, process improvement, team leadership, training and development, product design, technical support
Experience: 5+ years of relevant experience
Salary: $145,000 - $214,000
Type: Full-time
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…

Meta

Enablement Lead - Product Quality Programs Burlingame
Skills & Focus: Electronic Quality Management System (eQMS), Corrective Action Preventive Action (CAPA), First Article Inspection (FAI), Cross-Functional Teams, Data Analysis, Quality Management Principles, FDA, ISO 13485, Change Management, Quality Solutions
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: 5+ years of experience in product quality management
Salary: $122,000/year to $177,000/year + bonus + equity + benefits
Type: Full Time
Benefits: In addition to base compensation, Meta offers benefits.
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

Novo Nordisk

Vice President - Cell Therapy Global Manufacturing Fremont
Skills & Focus: global manufacturing, cell therapy, clinical stage, biopharmaceutical, leadership, GMP, stakeholders, project management, supply chain, innovation
About the Company: Novo Nordisk is a global health care company committed to discovering and developing innovative medicines to help people living with diabetes lead longer, heal…
Experience: 15+ years of relevant experience from biopharmaceutical manufacturing required.

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

Google

Staff Hardware Engineer, Quality Systems, Raxium Fremont
Skills & Focus: Quality Management Systems, ISO 9001, semiconductor, internal audits, compliance, document control, quality audits, training programs, corrective actions, continuous improvement
About the Company: Google is a global technology company focused on organizing the world's information and making it universally accessible and useful.
Experience: 8 years
Salary: $174,000-$258,000
Type: Full-time
Benefits: Bonus, equity, health benefits, and others.

Neuralink

Senior Mechanical Engineer Fremont
Skills & Focus: mechanical assemblies, biocompatibility, manufacturability, FMEAs, surgical robots, medical device design, ISO 13485, ISO 10993, multi-DoF actuated devices, verification and validation tests
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 mechanical engineering industry experience
Salary: $122,000 — $226,000 USD
Type: Full-time
Benefits: An opportunity to change the world and work with some of the smartest and most talented experts; Growth potential; Exce…

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…

Alamar Biosciences, Inc.

Manufacturing Associate II Fremont
Skills & Focus: manufacturing, biological reagents, ISO 13485, Good Manufacturing Practice, biochemistry, troubleshooting, quality system regulations, documentation practices, team player, process improvement
About the Company: At Alamar Biosciences, we are on a mission to transform the field of proteomics for the early detection of cancer and other diseases.
Experience: 4+ years of relevant experience in reagents manufacturing.
Salary: $80,000 - $90,000 + bonus + equity + benefits
Type: Full-time

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.

Raxium

Document Control Specialist Fremont
Skills & Focus: document control, records management, eDMS, semiconductor, ISO9001, Product Life-cycle Management, quality systems, documentation, compliance, audits
About the Company: Google's Raxium display group has established a revolutionary semiconductor materials display technology that enables new functionality in display products, br…
Experience: 5 years of experience in document control, records management, or administrative roles, including experience with electronic document management systems.
Salary: $115,000-$166,000 + bonus + equity + benefits
Type: Full-time
Benefits: Learn more about benefits at Google.

Johnson & Johnson

Sr. R&D Technician - Shockwave Fremont
Skills & Focus: R&D Technician, Medical Devices, Product Development, Testing, Prototyping, Fabrication, Good Manufacturing Practices, Documentation, Cross-Functional Teams, Innovative Products
About the Company: Johnson & Johnson is a global leader in healthcare innovation, known for creating a world where complex diseases are prevented, treated, and cured.
Experience: Minimum of 5 years’ experience as an R&D technician in the medical device industry or Associate’s degree with 3 years’ experience.
Salary: $25.91-$41.36 hourly
Type: Fully Onsite
Benefits: Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, group legal insu…
R&D Engineer II (Sustaining) - Shockwave Fremont
Skills & Focus: R&D, Biomedical Engineering, Product Development, Medical Device, Design Control, FDA, ISO, Process Optimization, Validation Testing, Component Documentation
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: 2+ years in engineering or 1 year with a master's degree in Engineering
Salary: $86,000 - $138,000
Type: Fully Onsite
Benefits: Employees may be eligible for medical, dental, vision, life insurance, short- and long-term disability, business accide…

Arsenal Biosciences Inc.

Sr. Director, Quality Control Hayward
Skills & Focus: quality control, CAR T-cell therapies, solid tumors, clinical trials, team management, strategy development, compliance, project targets, organization design, 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. Our mission is to de…
Type: Full-time
Sr. Manager, Quality Engineering & Validation (QA for QC) Hayward
Skills & Focus: Quality Engineering, cell therapy, Quality Control, Change Control, Deviation, CAPA, Lab Investigations, method qualifications, Computerized System Validation, Risk Management
About the Company: A clinical-stage programmable cell therapy company engineering advanced CAR T-cell therapies for solid tumors.
Type: Full-time
Intern - Process Engineering Hayward
Skills & Focus: programmable cell therapy, CAR T-cell therapies, solid tumors, GMP-compatible, process characterization, Drug Product, data sets, regulatory filings, cross-functional team, phase-appropriate
About the Company: Arsenal Biosciences Inc. is a clinical stage programmable cell therapy company engineering advanced CAR T-cell therapies for solid tumors.
Type: Internship

Baxter

Sr Engineer, Quality Hayward
Skills & Focus: Quality Assurance, Engineering, Medical Devices, Product Safety, Healthcare Solutions, Patient Care, Innovation, Compliance, Manufacturing, Risk Management
About the Company: Baxter is a global leader in medical devices and solutions, dedicated to improving patient care through high-quality products and services.
Type: Full time
Benefits: Comprehensive benefits options reflecting the value placed in employees.
Sr Engineer, Quality Hayward
Skills & Focus: Quality Engineering, Process Optimization, Risk Management, Validation, Defect Prevention, Project Management, Technical Evaluations, GMP, Statistical Analysis, Cross-functional Teams
About the Company: Baxter is focused on saving and sustaining lives by manufacturing high-quality products. Their products and therapies are found in almost every hospital worldw…
Experience: Minimum 3 years in a regulated manufacturing environment
Salary: $88,000 - $121,000 annually
Type: Full-time
Benefits: Comprehensive benefits including medical and dental coverage, Employee Stock Purchase Plan, 401(k) with company matchin…
Sr Engineer, Quality Hayward
Skills & Focus: Quality, Engineering, Healthcare, Innovate, Manufacture, Patient Care, Diversity, Team Collaboration, R&D, Technical Skills
About the Company: People of Baxter: Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive…
Type: Full time
Benefits: Our comprehensive benefits options reflect the value we place in our employees.

Llnl

NIF Target Diagnostics Engineering and Science Group Leaders Livermore
Skills & Focus: technical leadership, management, engineering, diagnostic systems, project management, team guidance, problem solving, quality standards, design documentation, innovation

Lawrence Livermore National Laboratory

Senior Weapons Production Group Quality Engineer Livermore
Skills & Focus: Quality Engineering, Production, Compliance, NNSA, Documentation, Process Improvement, Quality Assurance, Engineering Authorization, Technical Guidance, Quality Standards
About the Company: LLNL is a premier research and development institution that addresses complex national security challenges related to weapons production and surveillance.
Type: Full-time

Hims & Hers

Sr. Manager, Manufacturing Site Operations Menlo Park
Skills & Focus: manufacturing operations, environmental controls, safety protocols, pharmaceutical manufacturing, compliance, GMP, FDA regulations, EHS, facility maintenance, continuous improvement
About the Company: Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining health…
Experience: 8+ years of experience in facility management, operations, or a related role.
Salary: $150K – $180K
Type: Full time
Benefits: Competitive salary & equity compensation, Unlimited PTO, comprehensive health benefits including medical, dental & visi…

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.

Eikon Therapeutics

Manager, Trial Master File (TMF) Operations Millbrae
Skills & Focus: Trial Master File, TMF, clinical trials, Quality Control, regulatory inspection, documentation, clinical study, Good Documentation Practices, eTMF, audit support
About the Company: Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biolog…
Experience: 6+ years of experience with a Bachelor's degree; or 4+ years of experience with a post graduate degree
Salary: $122,000 to $133,000
Benefits: 401k plan with company matching, Medical, dental and vision insurance, Mental health and wellness benefits, Paid time o…
Manager, Regulatory CMC Millbrae
Skills & Focus: Regulatory CMC, CMC strategy, Veeva, regulatory submissions, project management, compliance, pharmaceutical development, cross-functional collaboration, cGMP, risk management
About the Company: Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biolog…
Experience: Minimum of 8 years related experience
Salary: $135,000 - $147,250
Type: Full-time
Benefits: 401k with company matching, Medical, Dental, Vision insurance, Mental health and wellness benefits, paid time off, life…

Bd

Director, Reagent MFG Technical Engineering Milpitas
Skills & Focus: Manufacturing, Technical Engineering, Regulatory, Quality, Project management, Supply chain, ISO, FDA, Lean manufacturing, Product lifecycle
About the Company: BD is one of the largest global medical technology companies in the world.
Experience: Minimum twelve (12) years’ experience in product Manufacturing Technical Engineering
Salary: Competitive
Type: Full-Time
Benefits: Valuable, competitive package of compensation and benefits programs
Regulatory Affairs Specialist Milpitas
Skills & Focus: Regulatory Affairs, IVD devices, IVDR requirements, CE marking, regulatory assessments, technical documentation, medical devices, ISO standards, product changes, stakeholder collaboration
About the Company: BD is one of the largest global medical technology companies in the world, advancing the world of health™ by improving medical discovery, diagnostics and the d…
Experience: 1-2 years of experience in medical devices required
Salary: $73,300.00 - $121,100.00 USD Annual
Type: Full-Time
Benefits: Competitive package of compensation and benefits programs including opportunities for learning and development.
Director, Instrument Manufacturing Engineering Milpitas
Skills & Focus: Manufacturing Engineering, Program Management, Quality Assurance, Regulatory Compliance, Lean Manufacturing, Continuous Improvement, Product Lifecycle, Project Management, Engineering Leadership, Medical Devices
About the Company: BD is one of the largest global medical technology companies in the world, focused on advancing health through innovative solutions across various medical fiel…
Experience: Minimum ten (10) years’ experience in Program Management
Salary: Competitive
Type: Full-Time

Bd (Becton, Dickinson And Company)

Staff Design Quality Engineer Milpitas
Skills & Focus: quality management, product development, design control, risk management, software quality, regulatory compliance, project leadership, continuous improvement, stakeholder communication, team dynamics
About the Company: BD is one of the largest global medical technology companies in the world, advancing the world of health.
Experience: Minimum of 5 years' experience supporting product development lifecycle in medical or pharmaceutical industry
Salary: Competitive
Type: Full-Time
Benefits: Includes workplace accommodations, emphasis on learning, growing, and thriving.

Samsung Research America

Director of R&D, Health Device Hardware Mountain View
Skills & Focus: Digital Health, Wearables, Health Devices, Hardware Development, Regulatory Clearance, Cross-functional Teams, Prototyping, Consumer Electronics, Medical Devices, Team Leadership
About the Company: Samsung Research America focuses on developing and commercializing innovative digital health products and solutions through a collaborative team that encompass…
Experience: 14+ years in hardware development and hardware manager roles, preferably including experience in developing consumer-oriented medical devices or health products.
Salary: $257,200 — $399,300 USD
Type: Full-time
Benefits: Comprehensive compensation package with annual bonus eligibility and generous benefits to help you live life well.

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…

Google

Program Manager III, Software Development, Pixel Mountain View
Skills & Focus: Software Development, Program Management, Cross-functional Projects, Hardware, Embedded Software, Risk Management, Documentation, Medical Software, Quality Assurance, Regulatory Compliance
About the Company: Google is a global technology leader focused on improving the world through innovative digital products and solutions.
Experience: 5 years of experience in program or project management
Salary: $147,000-$216,000
Type: Full-time
Benefits: Includes bonus, equity, and other benefits

Samsung Research America

Staff Systems Engineer Mountain View
Skills & Focus: medical device, regulatory submissions, quality management system, algorithm development, verification and validation, clinical studies, safety and effectiveness, data analysis tools, design control, risk management
About the Company: Our mission is to empower people to live healthier lives by leveraging our wearables, smartphones, medical devices, AI, and health services. We research, devel…
Experience: 6+ years of relevant experience in medical device product development, preferably with experience in algorithm development, verification and validation, and/or regulatory affairs.
Salary: $183,100 — $251,950 USD
Type: Full-time
Benefits: Annual bonus eligibility and generous benefits to help you live life well.

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…

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…

Guardant Health

Software Quality Assurance Engineer Palo Alto
Skills & Focus: Software Quality Assurance, Verification and Validation, FDA regulations, Risk Management, ISO 13485, Software Development Life Cycle, GxP documentation, Hazard Analysis, CAPA, Cross-functional teams
About the Company: Guardant Health is a biotechnology company that focuses on developing blood tests for cancer detection and treatment monitoring.
Experience: 5+ years in software quality assurance, particularly in FDA-regulated environments
Type: Full-time
Software Quality Assurance Engineer Palo Alto
Skills & Focus: Software Quality Assurance, Verification and Validation, Risk Management, FDA regulations, ISO standards, Software Development Life Cycle, Documentation Authoring, Audit Remediation, Quality Improvement, Regulatory Compliance

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.

10x Genomics

Senior Quality Engineer Pleasanton
Skills & Focus: Quality Engineer, Regulatory Standards, FDA, ISO, GMP, Supplier Quality Management, CAPA, Risk Assessment, Six Sigma, Continuous Improvement
About the Company: At 10x Genomics, accelerating our understanding of biology is more than a mission for us. It is a commitment. This is the century of biology, and the breakthro…
Experience: 7 years of experience in quality engineering, with a focus on supplier and product quality
Salary: $135,500 — $183,300 USD
Type: Full-time
Benefits: Equity grants, comprehensive health and retirement benefit programs, annual bonus program or sales incentive program.

Adverum Biotechnologies, Inc.

Project Manager, CMC Redwood City
Skills & Focus: CMC, Project Management, Pharma, Process Development, Quality Control, Quality Assurance, Meeting Facilitation, Timeline Management, GMP Manufacturing, Clinical
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: 1-2 years of project management experience in the Pharma CMC space
Salary: $73,500 - $82,536 a year
Type: Full Time
Benefits: Employees in this position are eligible to participate in the applicable Company equity incentive award plan. The amoun…

Biomea Fusion, Inc.

Director, Chemical Development & Drug Substance Manufacturing Redwood City
Skills & Focus: Chemical Development, Drug Substance Manufacturing, cGMP, Quality by Design (QbD), process characterization, small molecule drugs, experimental background, strategic thinking, interpersonal skills, analytical approach
About the Company: Biomea Fusion values bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients.
Experience: Master's degree with 10 years or more or Ph.D. with 7 years or more relevant experience in small molecule process chemistry.
Salary: $210,000 to $230,000
Type: Full-time
Benefits: Competitive cash compensation, including discretionary bonus program, equity awards and comprehensive benefits program.

Guardant Health

Senior Quality Engineer Redwood City
Skills & Focus: Quality Engineer, in vitro diagnostic, Design Controls, Risk Management, Change Control, Validation, Quality Management System, FDA regulations, ISO 13485, Continuous Improvement
About the Company: Guardant Health is a company that focuses on in vitro diagnostic products and innovative healthcare solutions.

Adicet Bio, Inc.

Manufacturing Associate 2/3 – Cell Therapy Redwood City
Skills & Focus: GMP, ASEPTIC, cell therapy, manufacturing, troubleshooting, bioprocess equipment, cell processing, SOP, environmental monitoring, quality assurance
About the Company: Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cance…
Experience: 1-3 years of experience in clinical processing and/or cell culture operations preferably in a GMP environment.
Salary: $84,000 - $130,000 USD
Type: Full-time
Benefits: competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stoc…
Director, Clinical Quality Assurance Redwood City
Skills & Focus: Clinical Quality Assurance, GCP, Clinical Trials, Regulatory Compliance, Audit Plans, Risk-based Quality Oversight, SOPs, Quality Management System, Inspection Readiness, Training Program
About the Company: Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cance…
Experience: 7-10+ years of experience working within the Clinical Operations, Regulatory, or Quality environment in the pharmaceutical or biotechnology industry.
Salary: $186,000 — $257,000 USD
Type: Full-time
Benefits: Competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stoc…

Carbon, Inc.

Senior Chemical Regulatory Specialist Redwood City
Skills & Focus: chemical regulations, regulatory compliance, REACH, CLP, TSCA, Prop 65, Sustainability, hazard classification, regulatory audits, 3D printing
About the Company: At 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 t…
Experience: 5-10 years
Salary: $115,200 - $199,200
Type: Temporary
Benefits: Comprehensive total rewards package that includes equity, benefits, and time off programs.

Arcellx

Specialist II, MSAT and Manufacturing Redwood City
Skills & Focus: cell therapy, manufacturing activities, aseptic processing, Good Manufacturing Practices, continuous improvement, Technical Support, Documentation, Quality Compliance, clean room environment, collaboration
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: 5+ years of industry experience in cell therapy manufacturing
Salary: $110,000 - $120,000 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…

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

Arcellx

Quality Systems Coordinator Redwood City
Skills & Focus: cell therapy, immunotherapies, quality system, Veeva, SOP's, document control, training, metrics, operational excellence, clinical-stage biotechnology
About the Company: a public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable …
Type: Full-time