270 quality systems jobs at 183 companies in Massachusetts

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Director, Quality Systems
Framingham, Massachusetts, United States
$192k-$248k/yr OnsiteFull Time
Replimune
ReplimuneNASDAQ: REPL: Develops oncolytic immunotherapies for cancer treatment.
10+ YOE10+ years in pharmaceutical quality/quality systems, experience with eDMS/MasterControl, inspection management, change control/CAPA, training, vendor management, and quality metrics; bachelor’s degree required.
MasterControl
2d
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Quality Systems Engineer III
Indianapolis or Quincy or Plainfield
$82k-$156k/yr RemoteFull Time
Boston Scientific
Boston ScientificNYSE: BSX: Developing and manufacturing innovative medical devices for less-invasive treatments.
Requires a bachelor's degree in engineering or a related technical discipline, quality engineering and quality systems knowledge, data analysis, problem-solving, communication, and cross-functional collaboration.
CAPA
1mo
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Quality Systems Engineer
Devens, Massachusetts, United States
$75k-$104k/yr OnsiteFull Time
VulcanForms
VulcanForms: Provides industrial-scale metal additive manufacturing and precision machining services.
3+ YOE3+ years in medical device or aerospace quality with knowledge of FDA requirements, ISO 13485/AS9100/ISO9001, QMS, CAPA, NCR, document control, procedure writing, audits, and quality metrics/KPIs.
1mo
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Senior Quality Systems Specialist
Boston, Massachusetts, United States
$95k-$105k/yr OnsiteFull Time
ABCorp
ABCorp: Produces secure payment cards and provides additive manufacturing solutions.
5+ YOE5+ years in quality assurance/systems in regulated manufacturing; experience with CAPA, deviations, investigations, change and document control, audits, SOPs, root cause analysis, QMS/ERP, and strong written documentation and cross-functional collaboration.
QMS, ERP
1mo
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Sr. Quality Systems Engineer
Woburn, Massachusetts, United States
$94k-$119k/yr HybridFull Time
Sirtex Medical
Sirtex Medical: Manufactures targeted radiation therapies for inoperable liver cancer patients.
5+ YOEBachelor's in engineering/life sciences required, 5+ years quality systems experience in medical device/pharma/biotech, proven eQMS administration (Veeva, MasterControl, ETQ, TrackWise), and strong knowledge of 21 CFR Part 820, ISO 13485, MDSAP.
Veeva Vault, MasterControl, ETQ, TrackWise, eQMS, Power BI, Tableau, Microsoft Excel
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Manager, Quality Systems
Newburyport, Massachusetts, United States
$179k-$180k/yr OnsiteFull Time
Rochester Electronics
Rochester Electronics: Licensed semiconductor manufacturer and distributor for end-of-life components.
10+ YOE5+ MgmtBachelor's degree in engineering or related field, 10 years quality management experience, 5+ years supervisory experience, semiconductor manufacturing experience, knowledge of ISO9000/IATF16949/AS9100/J​EDEC, SPC/LEAN/6 Sigma, auditing and strong computer and communication skills.
SPC, LEAN, 6 Sigma, ISO9000, IATF16949, MIL-PRF-38535, AS9100, JEDEC
3mo
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Director of Quality Systems
Lee, Massachusetts, United States
$100k-$150k/yr OnsiteFull Time
Berkshire Sterile Manufacturing
Berkshire Sterile Manufacturing: Sterile drug filling and formulation for clinical and commercial use.
10+ YOE5+ MgmtLead the Quality Systems division ensuring cGMP compliance; oversee QA processes, regulatory submissions, and client/gov inspections; 10+ years pharma quality with 5+ in leadership; BS in science, MS preferred; auditor certification preferred.
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Senior Quality Systems Engineer
Billerica, Massachusetts, United States
$93k-$160k/yr OnsiteFull Time
Access Vascular
Access Vascular: Develops biomaterial catheters that reduce clinical complications during intravenous therapy.
5+ YOEBachelor's in Engineering or Life Sciences; 5+ years quality systems in medical devices; QMS experience (FDA 21 CFR Part 820, ISO 13485); CAPA, document control, audits; CQE/CMDA or ISO Lead Auditor a plus.
Greenlight Guru, MasterControl, ETQ, eQMS platforms
1d
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Quality Systems Engineer III
Indianapolis or Plainfield or Quincy
$82k-$156k/yr RemoteFull Time
Boston Scientific
Boston ScientificNYSE: BSX: Manufacturer of interventional medical devices and technologies.
Bachelor's degree in engineering or a related technical field; quality engineering, process controls, CAPA, root cause analysis, continuous improvement, data analysis, communication, and cross-functional collaboration skills required.
CAPA
1d
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Quality Systems Engineer III
Indianapolis or Plainfield or Quincy
$82k-$156k/yr RemoteFull Time
Boston Scientific
Boston ScientificNYSE: BSX: Developer and manufacturer of innovative medical devices and therapies.
Bachelor's degree in engineering or a related technical field; quality engineering, process controls, CAPA, root cause analysis, data analysis, problem-solving, communication, and cross-functional collaboration skills required.
CAPA
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Director, Quality Systems & Compliance
Waltham, Massachusetts, United States
$190k-$260k/yr OnsiteFull Time
ElevateBio
ElevateBio: Develops and manufactures cell and gene therapies.
12+ YOE12+ years biopharma experience with leadership in Quality Systems; Business System Owner experience in GxP; expertise with eQMS/DMS/LMS/SAP/LIMS/MES; Veeva Vault preferred; familiarity with AI/ML, data integrity, CSV/CSA, and digital transformation.
eQMS, DMS, LMS, SAP, LIMS, MES, Veeva Vault
1mo
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Senior Specialist or Manager, Quality Systems
Watertown, Massachusetts, United States
$85k-$200k/yr OnsiteFull Time
Kymera Therapeutics
Kymera TherapeuticsNASDAQ: KYMR: Develops targeted protein degradation medicines to treat human diseases.
5+ YOEBachelor's in life sciences, 5+ years quality systems/GxP/document control experience in a sponsor organization, hands-on eQMS administration, GxP training program management, knowledge of 21 CFR Part 11 and ICH E6(R3).
Veeva Vault, Microsoft Word, Microsoft Excel, Microsoft PowerPoint
1mo
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Associate Director, Quality Management Systems
Waltham, Massachusetts, United States
$160k-$195k/yr OnsiteFull Time
Dyne Therapeutics
Dyne TherapeuticsNASDAQ: DYN: Developing therapeutics for genetically driven neuromuscular diseases.
8+ YOE8+ years in biotech/pharma with QMS ownership; bachelor’s in scientific discipline or quality systems; expertise with GxP, eQMS (Veeva, MasterControl), eDMS/LMS, strong strategic, communication, and risk-management skills.
Veeva eQMS, MasterControl, eDMS, LMS
1mo
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Senior Quality Systems Engineer
Medway, Massachusetts, United States
$93k-$116k/yr OnsiteFull Time
TE Connectivity
TE ConnectivityNYSE: TEL: Manufacturer of electronic connectors and sensors for global industries.
5+ YOEBachelor's in engineering/science or related, 5+ years related experience, ISO 13485 knowledge, audit and CAPA experience, eQMS experience, strong investigation and communication skills.
eQMS
2w
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Manager, Quality Systems
Cambridge, Massachusetts, United States
$135k-$150k/yr OnsiteFull Time
Editas Medicine
Editas MedicineNASDAQ: EDIT: Developing CRISPR-based gene editing therapies for serious diseases.
6+ YOEBS in a scientific discipline and 6+ years in quality roles; expertise with QMS, electronic document systems, vendor management, cGMP, ICH Q10 and FDA CFRs; experience with biologics and gene therapy products.
Veeva QualityDocs, Veeva QMS, ComplianceWire
1w
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Associate Director, Quality Systems
Bedford or Waltham
$185k-$209k/yr HybridFull Time
Stoke Therapeutics
Stoke TherapeuticsNASDAQ: STOK: Develops RNA-based therapies for severe genetic disorders.
10+ YOEBS/BA in life sciences or chemistry,10+ years in biotech/pharma quality, QMS and computerized quality systems experience, strong FDA/EU/ICH GMP knowledge, Lean/Six Sigma experience, inspection/audit experience.
Veeva
2mo
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Quality Systems Analyst II
Westford, Massachusetts, United States
$61k-$123k/yr OnsiteFull Time
Abbott
AbbottNYSE: ABT: Provides medical devices, diagnostics, and science-based nutritional products.
3+ YOEBachelor's degree or equivalent; 3+ years in manufacturing; strong MS Office; SQL/Reporting; QA data analysis; ability to travel; regulatory experience preferred.
Microsoft Office, SAP, InfoMed, SQL Server, Reporting Services
2mo
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Quality Control Systems Manager
Massachusetts, United States
$110k-$130k/yr OnsiteFull Time
Charter Contracting Company
Charter Contracting Company: Provider of civil and environmental remediation construction services.
5+ YOELead CQCP, inspections, documentation, and team management; 5+ years construction QC; USACE CQM certification; bachelor's degree preferred.
2mo
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Quality Systems Analyst II
Westford, Massachusetts, United States
$61k-$123k/yr OnsiteFull Time
Abbott
AbbottNYSE: ABT: Manufactures medical devices, diagnostics, and nutritional health products.
3+ YOEBachelor's degree or equivalent; minimum 3 years in manufacturing; strong MS Office; experience with automated databases; SQL knowledge; SAP/InfoMed experience preferred; ability to travel.
Microsoft Office, SQL Server, Reporting Services, Analysis Services, SAP, InfoMed, MS SQL, Automated databases
2d
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Vice President, Corporate Quality Systems
Princeton or Braintree or Mansfield or Columbia
$225k-$316k/yr OnsiteFull Time
Integra LifeSciences
Integra LifeSciencesNASDAQ: IART: Manufacturing surgical instruments and regenerative medical technology devices.
18+ MgmtBachelor's degree required; master's preferred. Requires 18+ years leading teams, regulated-industry experience, medical device quality expertise, FDA and international regulatory knowledge, and change-management skills.
CAPA, Six Sigma, FDA Part 820, ISO 13485, CMDR, MDR, MDSAP, JPAL