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216 quality compliance jobs at 148 companies in Boston, MA

3mo
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Sr. Director, Quality Compliance
Lexington, Massachusetts, United States
$250k-$273k/yr OnsiteFull Time
Kiniksa Pharmaceuticals
Kiniksa PharmaceuticalsNASDAQ: KNSA: Developing and commercializing therapies for cardiovascular and inflammatory diseases.
12+ YOE12+ years in pharmaceutical Quality Assurance/Compliance; advanced scientific degree; GMP/GCP/GLP experience; inspections; supplier quality; leadership.
Veeva, TrackWise
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Quality & Compliance Manager
Doylestown or New Britain or Exeter or Seabrook
OnsiteFull Time
Peregrine Surgical
Peregrine Surgical: Manufacturer of specialized ophthalmic and vitreoretinal surgical instruments.
5+ YOERequires 5+ years in senior medical device or pharmaceutical quality assurance, FDA or Notified Body inspection experience, people management, Microsoft Office proficiency, and fluent English.
Microsoft Office
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Quality & Compliance Manager
New Britain or Exeter or Seabrook
OnsiteFull Time
Dutch Ophthalmic Research Center
Dutch Ophthalmic Research CenterFrankfurt Stock Exchange: AFX: Manufactures surgical equipment and instruments for eye surgery.
5+ YOERequires 5+ years in senior medical device or pharmaceutical quality assurance, FDA or Notified Body inspection experience, people management, advanced Microsoft Office, and fluent English.
Microsoft Office, FDA, ISO 13485
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Associate Director, Digital Quality Compliance
Cambridge, Massachusetts, United States
$165k-$223k/yr RemoteFull Time
Alnylam
AlnylamNasdaq: ALNY: Developing and commercializing RNA interference (RNAi) therapeutics for diseases.
8+ YOEBachelor's degree and 8+ years in quality within biotech/pharma, experience with SAP/Veeva/LIMS, strong GxP and data governance knowledge, Quality Risk Management experience, and excellent communication skills.
SAP, Veeva Vault Quality, LIMS, DocuSign, Kneat, Ready Room, Quality Insights & Analytics, MES, ERP, SAP Quality Management (QM)
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Quality Systems and Compliance Lead
Dallas or Boston or San Bruno or Raleigh
$142k-$213k/yr HybridFull Time
Verily
Verily: Developing data-driven technologies for clinical research and precision health.
8+ YOEBachelor's plus 8+ years in quality/regulatory for medical device or digital health, ISO 13485 and FDA QMSR experience, CAPA/risk management per ISO 14971, IEC 62304, SaMD/AI/ML quality experience, QMS leadership and team development.
Jira, GitHub, Google Workspace
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Associate Director, Quality Compliance
Somerville, Massachusetts, United States
$144k-$195k/yr HybridFull Time
Genetix Biotherapeutics
Genetix Biotherapeutics: Developing and commercializing curative gene therapies for rare diseases.
10+ YOEBachelor's degree with 10+ years QA/GxP experience; strong validation and product lifecycle expertise; in-depth US/EU GMP and ICH knowledge; experience with CMOs/CTOs and inspection readiness.
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4w
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Quality Assurance Compliance Specialist I
Chelmsford, Massachusetts, United States
$60k-$70k/yr OnsiteFull Time
ZOLL Medical
ZOLL Medical: Manufactures medical devices and software for emergency care.
0+ YOESupport QMS, CAPA, audit programs, UDI and regulatory compliance; familiarity with FDA QSR, ISO 13485, MDR, MDSAP; 0–2 years in regulated industry; strong attention to detail and communication.
eQMS, UDI, GUDID, EUDAMED
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Director CMC Quality Compliance (Hybrid)
Boston, Massachusetts, United States
$185k-$277k/yr HybridFull Time
Vertex Pharmaceuticals
Vertex PharmaceuticalsNASDAQ: VRTX: Develops and sells prescription drugs for serious genetic diseases.
10+ YOE3+ MgmtExpert knowledge of global GMP and inspection readiness; Bachelor's in scientific/allied field required; ~10 years experience with 3 years management; strong leadership, risk-based decision making, and quality governance skills.
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Senior Director, Quality Management Systems & Compliance
Cambridge or United States
$252k-$308k/yr RemoteFull Time
Intellia Therapeutics
Intellia TherapeuticsNASDAQ: NTLA: Develops curative gene-editing treatments using CRISPR technology.
15+ YOE15+ years pharmaceutical quality/compliance leadership; deep GxP and QMS knowledge; inspection and Health Authority experience; strategic, analytical, and people leadership; BS/MS/PhD in science/engineering/pharmacy/medicine.
21 CFR 11, Annex 11, GAMP 5
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Quality and Compliance Manager
Exeter or Seabrook or New Britain
OnsiteFull Time
ZEISS
ZEISS: Produces high-precision optical systems and optoelectronic technologies.
5+ YOEBachelor's in engineering, 5+ years senior QA experience in medical device/pharma, QA qualifications (six-sigma, lean, ASQ), experience with FDA/Notified Body inspections, people management, and advanced Microsoft Office skills.
Microsoft Office, PFMEA, CAPA
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Head of Quality Compliance
Framingham, Massachusetts, United States
$161k-$233k/yr OnsiteFull Time
Sanofi
SanofiEuronext Paris: SAN: Researches, develops, and manufactures medicines and vaccines globally.
8+ YOE8+ MgmtDegree in science and 8+ years cGMP experience, demonstrated regulatory inspection leadership, strong knowledge of FDA/EMA/ICH regulations, project management, and people leadership.
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GelSight: Director of Compliance and Quality
Waltham, Massachusetts, United States
OnsiteFull Time
South 8 Technologies
South 8 Technologies: Developing liquefied gas electrolyte technology for lithium batteries.
10+ YOE10+ years quality management experience in defense/manufacturing, BA/BS required, ISO certification experience, QMS implementation, audit and supplier oversight, leadership and continuous improvement skills.
Document Management, CRM, ERP, PLM, MES, Six Sigma, 8D
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Associate Director, Clinical Quality Compliance
Bedford, Massachusetts, United States
$192k-$215k/yr HybridFull Time
Stoke Therapeutics
Stoke TherapeuticsNASDAQ: STOK: Develops RNA-based therapies for severe genetic disorders.
8+ YOEBS/BA, MS, or PhD with 8+ years in biotech, pharma, or CRO; knowledge of FDA, EU, and ICH GCP/GCLP regulations; auditing, risk management, communication, and collaboration skills.
TANGO, FDA, EMA, ICH, CRO, CAPA, TMF, ESPP
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Software Quality Engineer, Cybersecurity Compliance
Westford, Massachusetts, United States
$61k-$123k/yr OnsiteFull Time
Abbott
AbbottNYSE: ABT: Manufactures medical devices, diagnostics, and nutritional health products.
2+ YOEBachelor's in CS/biomedical/software engineering or equivalent; 2+ years software quality or medical device quality experience; knowledge of design controls, cybersecurity risk management, and regulatory standards; strong communication.
Jira, Jama, TestComplete, Coverity, C, C#, Visual Studio, Java, Python, Ruby, Perl
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Software Quality Engineer, Cybersecurity Compliance
Westford, Massachusetts, United States
$61k-$123k/yr OnsiteFull Time
Abbott
AbbottNYSE: ABT: Provides medical devices, diagnostics, and science-based nutritional products.
2+ YOEBachelor's in CS/biomedical/software or equivalent, 2+ years software quality engineering or medical device quality experience, knowledge of design controls and regulatory standards, experience with Jira/Jama and Agile, strong communication.
Jira, Jama, TestComplete, Coverity, Visual Studio, C, C#, Java, Python, Ruby, Perl
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Associate Director, Digital Quality Compliance
United States or Cambridge
$165k-$223k/yr RemoteFull Time
Alnylam Pharmaceuticals
Alnylam PharmaceuticalsNASDAQ: ALNY: Develops RNAi therapeutics to treat rare and common diseases.
8+ YOEBachelor's degree and 8+ years in quality within biotech/pharma; strong GxP data domain knowledge, SAP/Veeva/LIMS experience, Quality Risk Management expertise, and strong communication skills.
SAP, Veeva, LIMS, DocuSign, Kneat, Quality Insights & Analytics Dashboards, Ready Room, ERP, MES
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Manger, Transplant Quality & Regulatory Compliance
Boston, Massachusetts, United States
$120k-$150k/yr OnsiteFull Time
Beth Israel Lahey Health
Beth Israel Lahey Health: Integrated regional healthcare provider operating hospitals and clinical centers.
5+ YOEBachelor’s degree; 5+ years transplant quality/regulatory experience; CMS/OPTN knowledge; QAPI; certifications preferred.
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Chief of QA & Compliance
Braintree, Massachusetts, United States
$110k-$170k/yr OnsiteFull Time
Commonwealth of Massachusetts
Commonwealth of Massachusetts: Providing public services and governance to the people of Massachusetts.
6+ YOE2+ MgmtSenior leadership role requiring development and maintenance of quality management, compliance, internal audits, and document control; minimum 6 years professional experience with 2 years supervisory experience.
Document Management System (DMS)
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Quality Manager
Burlington, Massachusetts, United States
$182k-$228k/yr OnsiteFull Time
Signify
SignifyEuronext Amsterdam: LIGHT: Manufactures lighting products and connected IoT lighting systems.
7+ YOEBachelor's in Electrical Engineering, 7+ years in quality engineering within the lighting industry, experience managing quality teams, knowledge of ISO 9001, APQP/FMEA/PPAP/8D, compliance and product certification, 10% travel, US work authorization required.
8D, FMEA, DFMEA, APQP, PPAP, Design for Six Sigma (DfSS), ISO 9001:2015, BOM Check tool, IEC 61347-2-13, IEC 61347-1, IEC 62384, IEC 60598-1, CISPR15/EN55015, IEC 61000-3-2, IEC 61000-3-3, IEC 61000-4-4, IEC 61000-4-5, IEC 61000-4-6, CB, CE, RCM, Kite Marking, BIS, ENEC
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Quality Compliance Manager ISO experience needed
Cranston, Rhode Island, United States
OnsiteFull Time
Alloy Fasteners
Alloy Fasteners: Manufacturer and distributor of stainless steel fasteners and hardware.
2+ YOE2+ MgmtManage and maintain ISO 9001:2015 QMS; 2+ years QA/ISO experience with 2 years management; bachelor's or equivalent (engineering or science) preferred; Microsoft Office proficiency; travel to branches; strong writing and training skills.
Microsoft Office
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