Last updated: 2025-05-22

77 Quality Engineering jobs in Boston.

Hiring now: Regulatory Cmc Spec @ Orchard Th, Sr Validation Engr @ Cai, Svp Of Regulatory And Qua @ Ascidian T, Program Leader Medtech Qu @ Veeva Syst, Associate Dirdir Quality @ Strand The, Prod Mgr Cms Regulatory S @ Pa Consult, Consultant Manufacturing @ Kyverna Th, Laser Systems Engr Quantu @ Quera Comp, Customer Success Associat @ Ketryx, Dir Quality Management Sy @ Formation .Explore more at at kaamvaam.com

šŸ”„ Skills

compliance (14) project management (12) GMP (10) collaboration (9) regulatory compliance (9) continuous improvement (9) cGMP (9) medical devices (9) GxP (8) risk management (7)

šŸ“ Locations

Boston (22) Cambridge (21) Waltham (10) Chelmsford (6) Lexington (4) Marlborough (3) Peabody (3) Woburn (2) Burlington (1) Framingham (1)
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Orchard Therapeutics

Regulatory CMC Specialist Boston
Skills & Focus: regulatory, CMC, gene therapy, biologics, ATMP, documentation, compliance, submission, collaboration, product lifecycle
About the Company: Orchard Therapeutics is a global biotechnology gene therapy company dedicated to transforming the lives of people affected by rare diseases through the developā€¦
Experience: Minimum 3 years of regulatory CMC experience with biologics and/or Advanced Therapy Medicinal Products (ATMPs).
Type: Full-time

Cai

Senior Validation Engineer Boston
Skills & Focus: Commissioning, Qualification, Validation, pharmaceutical manufacturing, protocol writing, troubleshooting, documentation, project management, regulatory compliance, team coordination
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,ā€¦
Experience: 4-12 years
Salary: $102,100 - $111,700 a year
Type: Full-time
Benefits: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to emplā€¦

Ascidian Therapeutics

SVP of Regulatory and Quality Boston
Skills & Focus: regulatory strategy, quality assurance, compliance, regulatory filings, INDs, BLAs, NDA, GMP, GCP, risk management
About the Company: Ascidian is redefining the treatment of disease by rewriting RNA. Ascidian Therapeutics was founded to rewrite RNA by editing and replacing human exons. In ourā€¦
Experience: 15+ years
Benefits: We offer a generous total rewards plan that includes competitive compensation, stock options, and benefits, including aā€¦

Veeva Systems

Program Leader - MedTech Quality Boston
Skills & Focus: Vault Quality implementation, MedTech, Quality, Manufacturing technology, Account Management, Professional Services, Customer Success, program management, continuous improvement, life sciences industry
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 theā€¦
Experience: Experienced program leader
Type: Full-time
Benefits: Flexible work from home or in the office

Strand Therapeutics

Associate Director/Director, Quality Assurance Operations Boston
Skills & Focus: Quality Operations, GMP, clinical trial, biotech, regulations, partnering, compliance, audits, risk-based approach, product quality
About the Company: Strand Therapeutics is a clinical stage biotechnology company utilizing synthetic biology to genetically program mRNA to deliver truly revolutionary immunotherā€¦
Experience: 10+ years of quality operations experience in biotech
Salary: commensurate with role and experience
Type: Full-time
Benefits: health, dental, life, open PTO, onsite lunch catering, commuter support and more

Pa Consulting

Product Manager - CMS Regulatory Specialist Boston
Skills & Focus: Product Owner, software development, product vision, regulatory compliance, healthcare quality measurement, client interaction, cross-functional teams, product backlog, CMS regulations, training and support
About the Company: PA Consulting is a leading provider of managed software services for healthcare quality measurement and reporting, dedicated to improving healthcare outcomes tā€¦

Kyverna Therapeutics

Consultant, Manufacturing and Supply (Contract) Boston
Skills & Focus: manufacturing, supply chain, change controls, project management, cell therapies, cGMP, regulatory, process development, risk management, continuous improvement
Experience: 2+ years in pharmaceutical manufacturing, technology transfer & process development; at least 1 year in cell therapies
Type: Contract

Veeva Systems

Quality Engineer Boston
Skills & Focus: Quality Engineer, Vault Infrastructure, SaaS platform, life sciences, pharmaceuticals, biotechnology, medical devices, infrastructure modules, collaboration, fast-paced setting
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 theā€¦
Experience: Graduate or about to graduate
Type: Full-time
Benefits: Flexibility to work from home or in the office, collaborative environment, dedicated buddy support during onboarding.

Quera Computing, Inc.

Laser Systems Engineer - Quantum Systems Boston
Skills & Focus: laser systems, quantum computing, optical engineering, R&D, cross-functional collaboration, system integration, laser technologies, safety regulations, productization, high-precision
About the Company: QuEra Computing is pioneering the future of quantum computing technology.
Experience: Ph.D. in Optical Engineering, Physics, Electrical Engineering, or a related field. Exceptional candidates with a Master's degree and significant experience will also be considered.

Ketryx

Customer Success Associate Boston
Skills & Focus: customer success, client operations, professional services, systems engineer, Solutions Architect, Software as a Medical Device, SaMD, product management, technology, quality
About the Company: Ketryx is saving and improving lives by making medical software safe and reliable. We empower software teams building medical applications to create safe, secuā€¦
Experience: Minimum of 1 year professional experience (internships included) in the SaaS industry.
Salary: $65,000 - $90,000
Type: Full-time
Benefits: Competitive compensation, generous stock options possible, hybrid work model, generous PTO for full-time employees.

Formation Bio

Director, Quality Management Systems Boston
Skills & Focus: pharmaceutical quality systems, QMS, regulatory compliance, cGMP, quality assurance, internal and external audits, corrective and preventive actions, cross-functional collaboration, quality metrics, leadership
About the Company: Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. The company partners, acquires, or in-licenseā€¦
Experience: 12+ years
Salary: $210,000 - $300,000
Type: Full-time
Benefits: Equity, generous perks, hybrid flexibility, comprehensive benefits.

Cushman & Wakefield

CMMS Data Specialist Boston
Skills & Focus: CMMS, asset management, preventive maintenance, calibration, data management, GMP regulations, process improvement, engineering, reporting, data accuracy
About the Company: C&W Services is an Equal Opportunity employer to all protected groups, including protected veterans and individuals with disabilities. Discrimination of any tyā€¦
Salary: $40hr
Type: Full-time

Ketryx

Solutions Engineer Boston
Skills & Focus: Medical Device Sales, medical device software, software as medical device, SaMD, Software systems engineer, software in a medical device, SiMD, software systems engineering, software verification, software validation
About the Company: Ketryx is saving and improving lives by making medical software safe and reliable. We empower software teams building medical applications to create safe, secuā€¦
Experience: Minimum of 2 years of experience in customer success, technical support, sales engineering, or related.
Salary: $100,000 - $110,000 base + equity options *OTE may be negotiated based on experience level
Type: Full-time
Benefits: Competitive compensation, generous stock options, hybrid work model, generous PTO

Project Farma

Senior Project / Validation Engineer Boston
Skills & Focus: validation, project management, engineering, quality/compliance, teamwork, problem-solving, GxP best practices, technical documents, manufacturing processes, cross-functional collaboration
About the Company: Project Farma is the leading advanced therapy technical operations consulting company in the life science industry.
Experience: Bachelorā€™s degree in Life Science, Engineering, or related discipline and/or comparable military experience.
Salary: $50,000 - $240,000 USD
Type: Full-time
Benefits: Competitive salary based on experience, Aggressive bonus structure, Medical, Dental, and Vision insurance effective firā€¦

Alexion

Global Safety Program Lead (Senior Director) Boston
Skills & Focus: safety strategy, pharmacovigilance, risk management, clinical safety, team management, regulatory submissions, medical affairs, collaboration, compliance, project representation
About the Company: To transform the lives of people affected by rare diseases and devastating conditions by continuously innovating and creating meaningful value in all that we dā€¦
Experience: 5 years extensive relevant clinical, safety and risk management experience in the pharmaceutical, biotech, CRO industry, academia or Health Authorities

Cushman & Wakefield

GxP Automation Technician Boston
Skills & Focus: BMS, EMS, Automation Systems, GxP, Maintenance, Operational Proficiency, Safety Compliance, Troubleshooting, Preventive Maintenance, Project Coordination
About the Company: C&W Services provides facilities services within Cushman & Wakefield, focused on facility operations and management.
Type: Full-time

Project Farma

Project Engineer Boston
Skills & Focus: biomanufacturing, Project Management, cell and gene therapy, pharmaceutical, validation, quality compliance, technical delivery, engineering, supply chain, patient focused
About the Company: Project Farma (PF) is the leading advanced therapy technical operations consulting company in the life science industry. We provide biomanufacturing strategy aā€¦
Experience: 0-3 years of consulting and/or project engineer experience
Salary: Competitive salary based on experience
Type: Full-time
Benefits: Aggressive bonus structure, Medical, Dental, and Vision insurance effective your first day of employment, 401k Plan witā€¦

Orchard Therapeutics

Head of Pharmacovigilance Boston
Skills & Focus: Pharmacovigilance, Gene Therapy, Regulatory Compliance, Patient Safety, Global Strategy, Risk Assessment, Regulatory Submissions, Leadership, Biotech, Orphan Diseases
About the Company: Orchard Therapeutics is a global biotechnology gene therapy company dedicated to transforming the lives of people affected by rare diseases through the developā€¦

Seaport Therapeutics

Sr Manager, QA Document Control & Training Boston
Skills & Focus: Document Control, GxP, Quality, Regulatory, Standard Operating Procedures, Training, Compliance, Records Management, Electronic Document Management Systems, Project Management
About the Company: Seaport Therapeutics has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietā€¦
Experience: 6-8 years
Type: Hybrid

Kura Oncology

Director, Clinical Systems Boston
Skills & Focus: Clinical Operations, IT, biopharmaceutical, computer system validation, GxP, regulatory compliance, project management, stakeholder engagement, risk-based approach, system integrations
About the Company: Kura Oncology is a clinical-stage biopharmaceutical company discovering and developing personalized therapeutics for the treatment of blood cancers and solid tā€¦
Experience: 10+ yearsā€™ experience in Clinical Operations, IT, or related function in a biopharmaceutical setting.
Type: Full-time
Benefits: Career advancement/development opportunities, competitive comp package, bonus, 401K with employer contributions, generoā€¦

Johnson & Johnson

Sr. Director Systems Engineering & Testing - Orthopaedics Enabling Technology Boston
Skills & Focus: Systems Engineering, Testing, Orthopaedics, Digital Technology, Robotics, Medical Devices, Requirements Analysis, Validation and Verification, Risk Management, Product Development
About the Company: A multinational corporation known for its healthcare products, including pharmaceuticals, medical devices, and consumer health goods.

Whoop

Quality Systems & Regulatory Affairs Manager (Medical Devices) Boston
Skills & Focus: Quality Systems, Regulatory Affairs, Medical Devices, Regulatory Submissions, Quality Management System, Post-market Processes, Compliance, Product Development, Consumer Wearable, Problem-solving
About the Company: WHOOP empowers members to perform at a higher level through a deeper understanding of their bodies and daily lives.

Siphox Health

Senior Mechanical Design Engineer Burlington
Skills & Focus: mechanical designs, medical devices, diagnostic devices, injection molding, automated assembly, rapid prototyping, engineering tests, 3D modeling, cross-functional teams, ISO 13485
About the Company: SiPhox, supported by Y Combinator, Intel, and Khosla Ventures, is revolutionizing diagnostics through silicon photonics. Our in-vitro diagnostic (IVD) devices,ā€¦
Experience: 3+ years
Type: Full-time

Amgen

Specialist IS Business Systems Analyst Cambridge
Skills & Focus: CDS applications, GxP validation, systems analysis, machine learning, Agile methodologies, software engineering, quality assurance, cloud services, technology compliance, platform innovation
About the Company: At Amgen, we are relentless in applying the highest ethical standards to our products, services and communications. Our shared missionā€”to serve patients livingā€¦
Experience: Doctorate degree OR Masterā€™s degree and 2 years of systems analysis experience Or Bachelorā€™s degree and 4 years of systems analysis experience Or Associateā€™s degree and 8 years of systems analysis experience Or High school diploma / GED and 10 years of systems analysis experience
Salary: 115058.00 USD - 143472.00 USD
Type: Full time
Benefits: Our award-winning culture is collaborative, innovative, and science-based. We offer a range of benefits including healtā€¦

Biogen

Senior Regulatory CMC Device Lead Cambridge
Skills & Focus: regulatory CMC, medical devices, combination products, regulatory strategies, regulatory submissions, cross-functional teams, compliance, cGMP, regulatory intelligence, analytical abilities
About the Company: Biogen is dedicated to improving the lives of people living with serious neurological and neurodegenerative diseases. We bring innovative therapies to patientsā€¦
Experience: 5+ years of regulatory experience in the pharmaceutical or biotechnology industry.
Type: Hybrid

Amylyx Pharmaceuticals

Manager, Inventory Management and Planning Cambridge
Skills & Focus: Inventory Management, Supply Chain, Forecasting, Clinical Supply, Demand Analysis, Supply Planning, Inventory Reconciliation, QMS, Supply Chain Systems, GxP
About the Company: Amylyx is a clinical-stage pharmaceutical company focused on developing therapies for high unmet medical needs, including PBH, Wolfram syndrome, PSP, and ALS.
Experience: 5+ years of relevant experience in the Pharmaceutical Industry or relevant educational background

Scholar Rock

Director, CMC Outsourcing Drug Product Cambridge
Skills & Focus: biologics, drug product, manufacturing, GMP, CDMO, quality standards, contracts, technical documents, regulatory filings, supply chain
About the Company: Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmeā€¦
Experience: Minimum 10 years of relevant experience in biologics contract manufacturing management.
Type: Full-Time

Amgen

Senior Engineer, Design Transfer Specialist Cambridge
Skills & Focus: design transfer, medical devices, manufacturing processes, regulatory requirements, engineering testing, vendor management, process validation, continuous improvement, CAD, quality management
About the Company: At Amgen, we pioneer the world of biotech in our fight against the worldā€™s toughest diseases, focusing on oncology, inflammation, general medicine, and rare diā€¦
Experience: 4 years of Engineering experience with a Bachelor's degree, or 2 years with a Master's degree, or equivalent experience.
Salary: 119,195.00 USD - 147,867.00 USD
Type: Full-time
Senior Sterilization Engineer Cambridge
Skills & Focus: Sterilization, Biotechnology, Healthcare, Gas sterilization, Process validation, Regulatory compliance, Collaboration, Technical lead, Quality assurance, Project management
About the Company: Amgen is a pioneer in the world of biotech, dedicated to serving patients living with serious illnesses. With a focus on oncology, inflammation, general mediciā€¦
Experience: 4+ years of Engineering experience
Salary: 119,195.00 USD - 147,867.00 USD
Type: Full-time

Beam

Co-op in CMC (Chemistry Manufacturing and Controls) / External Manufacturing Cambridge
Skills & Focus: CMC, Chemistry Manufacturing, Controls, data analysis, KPI, metrics, project management, cross functional teams, SharePoint, Microsoft Project
Experience: Pursuing a technical degree in Science or Engineering, with an interest in project management
Type: Co-op

Blueprint Medicines

GxP Training Program Manager Cambridge
Skills & Focus: GxP Training, Procedural Document Control, eDMS, eLMS, Quality Culture, Regulatory Agencies, Training Program Management, GxP Software, Standard Operating Procedures, Quality Principles
Experience: 6+ years in industry with at least 5 years in training and document control

Regeneron Pharmaceuticals

Senior Validation Specialist- Computer System Validation Cambridge
Skills & Focus: Computer System Validation, FDA compliance, GMP, validation documentation, risk assessments, collaboration, quality compliance, validation protocols, change controls, GxP-regulated systems
About the Company: Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Our culture promotes an inclusive envirā€¦
Experience: 5+ years of relevant work experience
Salary: $82,600.00 - $134,800.00
Type: Contract
Benefits: Health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off

Novartis

Biomedical Research Submission Management, Associate Director Cambridge
Skills & Focus: regulatory submissions, submission management, cross-functional teams, NDA, MAA, submission planning, project management, quality standards, critical path activities, continuous improvement
About the Company: Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend peopleā€™s lives so that patients, healthcare professā€¦
Type: Hybrid

Biogen

Senior Regulatory CMC Device Lead Cambridge
Skills & Focus: Regulatory CMC, medical devices, combination products, regulatory strategies, submissions, compliance, cross-functional teams, project assignments, legislative developments, analytical abilities
Experience: 5+ years of regulatory experience
Type: Hybrid

Blueprint Medicines

Director of Environmental Health & Safety (EH&S) Cambridge
Skills & Focus: Environmental Health & Safety, EH&S programs, biopharma, safety protocols, regulatory compliance, employee safety, hazardous materials, incident preparedness, culture of continuous improvement, industry certification
About the Company: Blueprint Medicines is a global, fully integrated biopharmaceutical company that invents life-changing medicines, focusing on allergy/inflammation and oncologyā€¦
Experience: 10+ years of EH&S experience, with focus on building strong EH&S culture and leading teams to EH&S excellence.
Type: Full-time
Associate Director, Medical Writing Cambridge
Skills & Focus: medical writing, regulatory submissions, clinical data, cross-functional collaboration, document management, project management, regulatory compliance, Common Technical Document, quality control, standard operating procedures
About the Company: Blueprint Medicines is a global, fully integrated biopharmaceutical company that invents life-changing medicines. We seek to alleviate human suffering by solviā€¦
Experience: 7+ years of experience in medical/clinical/regulatory writing in the pharmaceutical/biotechnology/healthcare industry; 3+ years of regulatory document project management oversight/experience

Aditum Bio

VP of CMC Cambridge
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 Fā€¦
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 lā€¦

Amgen

Senior Engineer, Combination Products - Process Engineering Cambridge
Skills & Focus: process engineering, drug delivery, device manufacturing, failure investigations, design control, technical records, project management, collaboration, manufacturing processes, combination products
About the Company: At Amgen, if you feel like youā€™re part of something bigger, itā€™s because you are. Our shared missionā€”to serve patients living with serious illnessesā€”drives allā€¦
Experience: 10 years of Engineering and/or Operations experience
Salary: 119,195.00 USD - 147,867.00 USD
Type: Full time
Benefits: Competitive benefits and collaborative culture

Scholar Rock

Head of Global GxP Quality Cambridge
Skills & Focus: GxP, Quality, Regulatory Compliance, GMP, GCP, GLP, Quality Systems, Post-market Surveillance, Global Operations, Leadership
About the Company: Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for serious diseases with high unmet needs. The compā€¦
Experience: 15+ years of experience in biopharmaceutical Quality leadership roles
Type: Full-Time

Aditum Bio

Associate Director / Director R&D Quality Assurance Cambridge
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 Fā€¦
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

Relay Therapeutics

Manager, Quality Systems Cambridge
Skills & Focus: Quality Management System, vendor management, GxP, auditing, compliance, continuous improvement, risk assessment, Quality ambassador, Veeva QualityDocs, Inspection Readiness
About the Company: Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies toā€¦
Experience: 4+ years of experience in pharma/biotech Vendor Management and auditing.

Cullinan Therapeutics, Inc.

Senior Manager/Associate Director, Quality Management Systems Cambridge
Skills & Focus: quality management systems, cGxP regulatory standards, continuous improvement, collaboration, business needs, technology leverage, solution management, compliance, process streamlining, clinical-stage assets
About the Company: Cullinan Therapeutics, Inc.ā€Æ(Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients. We have strategically builtā€¦

Astrazeneca

Engineer II, Downstream Development, Viral Vector Product Development Cambridge
Skills & Focus: downstream development, viral vector purification, AAV manufacturing, experiments, tech-transfer, analytical data, process optimization, chromatography, filtration, documentation
About the Company: AstraZeneca is committed to making a difference by following the science to explore and innovate. We work towards treating, preventing, modifying, and even curā€¦
Experience: 3+ years (BS) or 0 years (MS) experience in the biotech industry, including internships or co-op experience
Salary: $87,000 to $130,000
Type: Full-time
Benefits: qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; health benefits including medical,ā€¦

Aditum Bio

Vice President of Regulatory Affairs Cambridge
Skills & Focus: regulatory strategies, FDA interaction, clinical development, regulatory filings, regulatory agency interface, strategic guidance, collaborations, vendor oversight, clinical trials, CMC regulatory
About the Company: A biotech venture capital firm co-founded by industry veterans Joe Jimenez, former CEO of Novartis, and Mark Fishman, former President of the Novartis Institutā€¦
Experience: Leading regulatory affairs at a growth-stage biotech, experience in relevant therapeutic areas such as psychiatry or neurology, strong track record in Regulatory Affairs and CMC Regulatory, including hands-on experience in Phase II clinical trials.
Salary: $335,000 to $365,000
Type: Full-time
Benefits: Medical, dental, vision, disability, life and 401k plan with match; flexible/non-accrued PTO; 12 paid holidays; parentaā€¦

Teleflex

Quality Engineer 2, Design Assurance Chelmsford
Skills & Focus: Design Assurance, New Product Development, Risk Management, Test Method Development, Validation, Design Verification, Regulatory Affairs, Hazard Analysis, DFMEA, Test Protocols
About the Company: Teleflex is a global provider of medical technologies, driven by the purpose to improve the health and quality of peopleā€™s lives. They focus on becoming the moā€¦
Experience: Two years of related experience required.

Teleflex Incorporated

Quality Engineer 2, Design Assurance Chelmsford
Skills & Focus: design assurance, new product development, risk management, design controls, design verification, validation, test method development, regulatory affairs, sustaining engineering, quality system
About the Company: As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of peopleā€™s lives. Through our vision to becoā€¦
Experience: Two years of related experience required.

Teleflex

Quality Engineer II, Design Assurance Chelmsford
Skills & Focus: Quality Engineer, Design Assurance, Process Validation, Risk Management, Statistical Techniques, Process Controls, Documentation, Audits, Root Cause Analysis, Medical Device
About the Company: Teleflex Incorporated is a global provider of medical technologies, driven by their purpose to improve the health and quality of peopleā€™s lives, offering a divā€¦
Experience: 2 to 5 years of quality engineering or design assurance experience (preferably in the medical device industry)
Type: Contract
Quality Engineer 2, Design Assurance Chelmsford
Skills & Focus: Design Assurance, New Product Development, Test Method Development, Regulatory Affairs, Risk Management, Design Verification, Validation, Data Analysis, Quality System, Collaboration
About the Company: As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of peopleā€™s lives. Through our vision to becoā€¦
Experience: Two years of related experience required.
Quality Engineer II, Design Assurance Chelmsford
Skills & Focus: Quality Improvement, Manufacturing, Regulatory Affairs, Risk Management, Test Method Development, Process Validation, Statistical Techniques, Documentation, Root Cause Analysis, Supplier Process Improvement
About the Company: As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of peopleā€™s lives. We offer a diverse portfolā€¦
Experience: 2 to 5 years of quality engineering or design assurance experience (preferably in the medical device industry).
Type: Contract

Teleflex Incorporated

Quality Engineer 2, Design Assurance Chelmsford
Skills & Focus: design assurance, new product development, risk management, test method validation, design verification, FDA regulations, ISO13485, collaboration, quality systems, data analysis
About the Company: Teleflex is a global provider of medical technologies focused on improving health and quality of life through a diverse portfolio in various therapy areas.
Experience: Two years of related experience required.

Staples, Inc.

Product Quality and Safety Specialist Framingham
Skills & Focus: Product Quality, Safety, Regulatory Compliance, Risk Management, Quality Assurance, Consumer Expectations, Data Analysis, Documentation, Cross-functional Teams, Continuous Improvement
About the Company: Staples is business to business. Our merchandising team aims to deliver the best value and selection to our customers through products, services and solutions ā€¦
Experience: 3+ years of experience in Product quality assurance, product safety, quality engineering, or a related field.
Type: On-site
Benefits: Flexible PTO (22 days), Holiday Schedule (7 observed paid holidays), Online and Retail Discounts, Company Match 401(k),ā€¦

Genezen

Manufacturing Associate Lexington
Skills & Focus: gene therapy, GMP, manufacturing operations, cGMP, cell culture, purification, SOP, production equipment, safety compliance, continuous improvement
About the Company: Genezen is focused on providing process development, producing GMP viral vectors, and providing cell transduction for gene and cell therapy clinical trials.
Experience: 2-4 years related cGMP industry experience or an Associateā€™s Degree in Life Sciences/Engineering field with 1 year of cGMP Manufacturing experience or Bachelorā€™s degree in Life Sciences/Engineering.
Type: Full-time
Benefits: Paid vacation days, paid sick time, 401(k) plan with company match, health care plans, FSA and HSA programs, dental & vā€¦
Quality Assurance Specialist II Lexington
Skills & Focus: Quality Management System, GMP, cGMP, deviations, Corrective and Preventive Actions (CAPAs), investigations, change controls, batch record review, data integrity, biologics/gene therapy
About the Company: The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vā€¦
Experience: 3-5 years of relevant GMP experience in pharma/biotech company, working within a quality system and regulated GMP environment
Benefits: Paid vacation days, paid sick time, 10 observed holidays + 2 floating holiday + 1 volunteer day, 401(k) plan with compaā€¦
Validation Manager Lexington
Skills & Focus: validation, cGMP, protocol generation, environmental qualification, risk assessments, technical writing, aseptic fill finish, clean rooms, qualifications activities, data analysis
About the Company: Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene anā€¦
Experience: 5-8 years of validation experience
Type: Full-time
Benefits: Paid vacation days, paid sick time, observed holidays, 401(k) plan with company match, healthcare plans, FSA and HSA prā€¦

Boston Scientific

Medical Device Toxicologist II Marlborough
Skills & Focus: toxicology, biocompatibility, ISO 10993, medical devices, regulatory standards, toxicity assessments, biological evaluation, risk assessment, glp studies, medical device development
About the Company: A leader in medical science for over 40 years, committed to solving healthcare challenges with innovative solutions to improve patient lives.
Experience: 2-3 years supporting medical devices
Salary: $72,800 - $138,300
Type: Hybrid (Onsite and Remote)
Principal Product Risk Specialist Marlborough
Skills & Focus: clinical product risk, risk analysis, regulatory standards, clinical evaluation reports, literature searches, risk assessment, clinical risk documents, FDA, safety signal detection, medical device
About the Company: A leader in medical science dedicated to solving health industry challenges through innovative solutions.
Experience: 5+ years in life sciences, engineering, or related field; 10+ years preferred
Salary: $99,100 - $188,300
Type: Hybrid
Benefits: Not specified in the posting
Senior Regulatory Affairs Specialist Marlborough
Skills & Focus: Regulatory Affairs, medical devices, FDA regulations, EU MDR, product development, submissions, compliance, regulatory strategies, clinical trials, sustaining engineering
About the Company: Boston Scientific specializes in medical devices for urology and other health conditions, aiming to improve patient lives through innovative solutions.
Experience: Minimum 4 years in Regulatory Affairs or related discipline in medical devices or drugs
Salary: $82,600 - $156,900
Type: Hybrid
Benefits: Comprehensive employee benefits package including health insurance, retirement plans, and professional development oppoā€¦

Johnson & Johnson

Quality Inspection I Peabody
Skills & Focus: quality control, inspection, medical device, microscope, GMP, ISO, GCP, data entry, visual inspection, manual inspection
About the Company: A global healthcare company dedicated to producing innovative medical products and solutions.
Experience: 1 year or less in a manufacturing environment
Salary: $21-28/hr
Type: Full-time
Benefits: Medical, dental, vision, life insurance, disability, 401(k), paid time off, performance bonuses.
Production Associate I Peabody
Skills & Focus: medical devices, assembly, inspecting, testing, cleanroom, quality checks, manufacturing procedures, line issues, continuous improvement, medical components
About the Company: A multinational healthcare company focused on medical devices, pharmaceuticals, and consumer health products.
Experience: 2 years of related work experience desired
Salary: $20-22 hourly
Type: Full-time
Benefits: Medical, dental, vision, life insurance, disability, 401(k), paid time off
Sr. Equipment Engineer - 2nd Shift Peabody
Skills & Focus: Equipment Engineering, Preventative Maintenance, Calibration, Good Manufacturing Practices, Validation, Troubleshooting, Production Manufacturing, Technical Support, Continuous Improvement, Medical Devices
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,ā€¦
Experience: Minimum of 5 years of experience in equipment engineering, preferably in the medical device manufacturing industry.
Salary: $105,000-$169,050
Type: Full-time
Benefits: Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, group legal insuā€¦

Boston Scientific

Product Builder I Quincy
Skills & Focus: assemble, operate equipment, inspect in-process medical devices, maintain quality, building product, production goals, quality assurance, manufacturing process, compliance, regulatory policies
Experience: 0 Years with high school diploma/degree/equivalent
Salary: $32,552 - $55,328
Type: Onsite

Tessera Therapeutics

Senior Manager, Clinical Supply Chain Somerville
Skills & Focus: clinical supply chain, biotechnology, clinical labeling, packaging, distribution, clinical trial material, vendor management, GMP, global regulatory compliance, Gene Editing
About the Company: Tessera Therapeutics is pioneering Gene Writingā„¢ā€” a new biotechnology designed to offer scientists and clinicians the ability to write small and large therapeuā€¦
Experience: 12+ years of clinical supply chain experience or Master's degree with 10+ years of experience.
Type: Full-time
Benefits: competitive package of base and incentive compensation, comprehensive benefits program including group medical, vision ā€¦

Ardelyx

QA Computer Systems Specialist Waltham
Skills & Focus: Quality Assurance, GxP computer systems, validation, risk assessments, regulatory requirements, FDA compliance, project management, SOPs, data integrity, enterprise system applications
About the Company: Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicā€¦
Experience: 5+ years of experience in a Quality environment or equivalent experience
Salary: $112,000-$136,000
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 marrā€¦
QA Computer Systems Specialist Waltham
Skills & Focus: Quality Assurance, GxP computer systems, validation, audit, risk assessment, regulatory requirements, SOPs, policy implementation, project management, data integrity
About the Company: Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicā€¦
Experience: 5+ years of experience in a Quality environment or equivalent experience
Salary: $112,000-$136,000
Type: Full-time
Benefits: Ardelyx offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks oā€¦
Executive Director, GCP, GLP and GVP Quality Waltham
Skills & Focus: Quality Assurance, GCP, GLP, PV, Risk Management, Regulatory Compliance, Audit Programs, Inspections, Clinical Development, Continuous Improvement
About the Company: Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicā€¦
Experience: 15+ years related experience, preferably in life sciences with 8+ years in GCP/GLP Quality and PV Quality
Salary: $269,000-$329,000
Type: Full-time
Benefits: 401(k) plan with generous employer match, 12 weeks paid parental leave, up to 12 weeks living organ and bone marrow leaā€¦

Dyne Therapeutics

Director, Drug Safety & Pharmacovigilance Scientist Waltham
Skills & Focus: pharmacovigilance, signal detection, risk management, regulatory compliance, documentation, training and development, safety reports, data analysis, collaboration, Good Pharmacovigilance Practices
About the Company: Dyne Therapeutics is discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveā€¦
Experience: Minimum of 10 years of experience in pharmacovigilance, with at least 2 years in a leadership role
VP, Technical Development Waltham
Skills & Focus: drug development, CMC, process transfer, biologics, bioconjugates, regulatory filings, process development, biologics manufacturing, drug specifications, cGMP
About the Company: Dyne Therapeutics is discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases, leveā€¦
Experience: 15+ years of relevant biopharmaceutical technical development and/or engineering experience

Dentsply Sirona, Inc

R&D Manager Waltham
Skills & Focus: Product Development, Medical Device, 3D CAD, Regulatory Documentation, Design Control, Project Management, Collaboration, Sustaining Engineering, Manufacturing, Innovation
About the Company: Dentsply Sirona is the worldā€™s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the ā€¦
Experience: 10 years professional experience with at least 5 years in precision medical device product development
Type: Hybrid

Invivyd

Associate Director, Clinical Quality Assurance and Compliance Waltham
Skills & Focus: Clinical Quality Assurance, Compliance, GCP, GLP, Regulatory, Clinical Development, Quality Systems, Audit, Training, Pharma/Biotech
About the Company: At Invivyd, Inc., we are dedicated to delivering protection from serious viral infectious diseases, starting with COVID-19. We leverage a proprietary integrateā€¦
Experience: A minimum of 6 years relevant GCP experience in pharma/biotech company
Type: Full-time

Dyne Therapeutics

Senior Manager, Analytical Development and Quality Control Waltham
Skills & Focus: analytical development, quality control, QC, analytical methods, validation, cGMP, biologics, small molecules, regulatory, CMC
About the Company: Dyne Therapeutics is discovering and advancing innovative life-transforming therapeutics for neuromuscular diseases, utilizing the FORCEā„¢ platform to develop tā€¦
Experience: 2 years in Analytical Development or QC or R&D, including analytical tools and practices for biologics and small molecules
Senior Manager, Clinical Supply Waltham
Skills & Focus: clinical supply, inventory management, drug development, compliance, project management, contract manufacturing, GxP, IVRS, CRO, deviations
About the Company: Dyne Therapeutics is discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveā€¦
Experience: Minimum of 5 years of related experience in the pharmaceutical industry with at least 3 years of direct experience in Global Clinical Supply Management.

Landmark Bio

Senior Specialist, Quality Assurance Operations Watertown
Skills & Focus: Quality Assurance, GMP, cell therapy, manufacturing, documentation, compliance, batch records, investigations, continuous improvement, performance objectives
About the Company: Landmark Bio translates groundbreaking research into life-changing medicines. We provide development, manufacturing, and regulatory capabilities to help early-ā€¦
Experience: 6-8 years in a biotechnology manufacturing environment
Type: Full-time

L3harris Technologies

Space Program, Quality Engineering Wilmington
Skills & Focus: Quality Engineer, space-based imaging systems, program quality plan, inspection, testing, compliance, nonconformities, Material Review Board, PFMEA, project management
About the Company: L3Harris is dedicated to recruiting and developing high-performing talent who are passionate about what they do. Our employees are unified in a shared dedicatiā€¦
Experience: Bachelorā€™s Degree and minimum 4 years of prior relevant experience.
Type: Full-time

Sirtex

Senior Regulatory Affairs Specialist Woburn
Skills & Focus: regulatory submissions, FDA, license renewals, registration, compliance, quality system, advertising, clinical trial, regulatory assessments, post-market compliance

Perkinelmer

Principal Systems Engineer Woburn
Skills & Focus: Systems Engineering, risk management, regulatory compliance, project leadership, biotechnology, medical devices, FDA, quality control, collaboration, data analysis
About the Company: Covaris, LLC (a PerkinElmer subsidiary) is a leading sample preparation solution provider in Biotechnology headquartered in Woburn, Massachusetts and has pioneā€¦
Experience: 8+ years of engineering experience, 5+ of Systems Engineering.
Type: Full Time