64 Quality Engineering jobs in San Jose.

Hiring now: Quality Engr I @ Penumbra, Dir Regulatory Document Q @ Exelixis, Research And Development @ Penumbra, Sr Quality Engr @ Penumbrain, Enablement Lead Prod Qual @ Meta, Medical Devices Quality M @ Facebook R, Staff Hardware Engr Quali @ Google, Rdprod Development Engr I @ Te Connect, Sr Mechanical Engr @ Neuralink, Principal Rd Proj Mgr Ear @ Johnson Jo.Explore more at jobswithgpt.com.

🔥 Skills

compliance (9) project management (8) Quality Assurance (8) Risk Management (8) Medical Devices (7) GMP (7) ISO 13485 (7) cell therapy (7) Quality Management System (6) medical devices (6)

đź“Ť Locations

Alameda (10) Fremont (10) Hayward (8) Redwood City (8) Palo Alto (6) Milpitas (4) Burlingame (3) Mountain View (3) San Carlos (3) Millbrae (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…

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

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.

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…

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…

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…

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.

Te Connectivity

R&D/Product Development Engineer II Fremont
Skills & Focus: R&D, product development, engineering support, material science, testing, project management, compliance, cost reduction, documentation, cross-functional teams
About the Company: TE Connectivity is a global industrial technology leader creating a safer, sustainable, productive, and connected future. Our broad range of connectivity and s…
Experience: 0-5 years
Salary: $114,800 - $172,200
Benefits: A comprehensive benefits package including health insurance, 401(k), disability, life insurance, employee stock purchas…

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…

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…

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,…

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.

Stryker

Associate R&D Lab Manager Fremont
Skills & Focus: engineering, R&D, medical devices, leadership, compliance, process development, staffing, technical resource, team development, budgeting
About the Company: Stryker offers innovative products and services in MedSurg, Neurotechnology, and Orthopaedics that help improve patient and healthcare outcomes. Alongside its …
Experience: Minimum 6 years of experience in engineering or related technical discipline in a highly regulated industry including medical device or pharmaceuticals.
Salary: $100,500.00 - $215,300.00 plus bonus eligible
Type: Full Time
Benefits: Health benefits including medical, dental, vision, critical illness, accident insurance, 401(k) plan, Employee Stock Pu…

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…

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.

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

Baxter

Manager Quality Assurance Hayward
Skills & Focus: Quality Assurance, cGMP compliance, Continuous Improvement, Regulatory inspections, Non-conformance report, Batch release activities, Training and development, Manufacturing operations, Problem-solving, Leadership skills
About the Company: Baxter International Inc. is a healthcare company that operates in more than 100 countries and provides a range of solutions that address the needs of patients…
Experience: 5+ years’ experience in Quality, Manufacturing, Engineering, or related field with 1-2 years of supervisory experience.
Salary: $112,000 - $154,000 annually
Type: Full-time
Benefits: Comprehensive compensation and benefits packages including medical and dental coverage, 401(k) plan, educational assist…

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

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.

Arsenal Biosciences Inc.

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

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…

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

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…

Eikon Therapeutics

Clinical Documentation & Systems Specialist (Clinical R&D) Millbrae
Skills & Focus: GxP standards, Document Management System, Learning Management System, Clinical System, Quality Management System, data collection, training records, clinical reports, Microsoft Office, team-oriented
About the Company: Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biolog…
Experience: Typically requires a minimum of 5 years of related experience with a Bachelor's degree; or 3 years and a Master's degree; or a PhD without experience; or equivalent work experience.
Salary: $113,000 to $123,500
Type: Full-time
Benefits: 401k plan with company matching; medical, dental, and vision insurance; mental health and wellness benefits; paid time …
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

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.

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.

Ardelyx

Senior Manager, SAS Programming Newark
Skills & Focus: SAS programming, statistical programming, clinical trials, regulatory compliance, data monitoring, SOPs, CDISC standards, lead programmer, program verification, FDA filings
About the Company: Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medic…
Experience: 10 years of SAS programming and 4+ years of pharmaceutical clinical trial experience serving as a Lead Programmer or equivalent experience
Salary: $176,000 - $216,000
Type: Full-time
Benefits: 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marr…

Impossible Foods

Quality Assurance Manager Oakland
Skills & Focus: Quality Assurance, Food Safety, Team Leadership, Compliance, Auditing, Continuous Improvement, HACCP, SSOP, GMP, Data Management
About the Company: Impossible Foods was founded to transform the global food system and reduce the impact of climate change by making the world’s most delicious, nutritious, and …

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

Delfi Diagnostics, Inc.

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…

Guardant Health

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

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…
Director, Regulatory Affairs Palo Alto
Skills & Focus: regulatory strategies, clinical development, non-clinical, CMC, submissions, project teams, regulatory requirements, international teams, drug-device combination products, regulatory dossiers
About the Company: A dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States, advancing programs in Endocrinology Rare Dis…
Experience: Minimum of 10 years overall regulatory experience
Salary: $200-225K/year
Type: Full-time
Benefits: 401(k) plan with company match, Medical, dental, and vision plans, Company-offered Life and Accidental Death & Dismembe…

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.

Veeva Systems

Senior Product Manager Pleasanton
Skills & Focus: Product Management, CRM, Product Roadmap, User Stories, Agile, Collaboration, Life Sciences, SaaS, Federal Regulatory Requirements, Configuration
About the Company: Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the…
Experience: 5+ years of product management experience
Salary: $120,000 - $200,000
Type: Full-time
Benefits: Medical, dental, vision, and basic life insurance; Flexible PTO and company paid holidays; Retirement programs; 1% char…

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…

Balsam Brands

Product Safety Manager Redwood City
Skills & Focus: Product Safety, Electrical Engineering, Compliance, Risk Management, Safety Standards, QA Auditors, Testing Protocols, Regulatory Documentation, Cross-Functional Collaboration, Consumer Electronics
About the Company: Balsam Brands is a global, omnichannel retailer with roots in holiday and home décor. Our flagship brand, Balsam Hill, is recognized for its quality and crafts…
Experience: 5+ years of experience in product safety management
Salary: $131,000 to $163,000
Type: Full-time
Benefits: Competitive compensation, comprehensive medical, dental, vision coverage, 401(k) match, paid holidays, paid sabbatical …

Adicet Bio, Inc.

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…
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
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…

Noah Medical

Principal Software Engineer, Lead San Carlos
Skills & Focus: Medical Robotics, Software Development, Cross-functional Teams, Design Reviews, Agile Development, Quality Standards, Software Architecture, Leadership, Mentoring, FDA Regulations
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 10 years of experience with at least 5 years in the medical device industry.
Salary: $209,800 - $262,200 USD
Type: Hybrid
Benefits: Comprehensive health insurance including Medical, Dental, and Vision + HSA and FSA options, Equity & Bonus Program, Lif…
Staff Software Test Engineer San Carlos
Skills & Focus: software testing, automation testing, regulatory compliance, Quality System documentation, hands-on experience, batch scripting, CI/CD systems, medical device industry, leadership skills, 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: Minimum of 10 years of experience in software test engineering.
Salary: $135,000 - $173,000 USD
Type: Full-time
Benefits: Competitive Salary, Comprehensive health insurance, Equity & Bonus Program, Life Insurance and Disability insurance, Me…
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+ …