298 quality systems jobs at 200 companies in Boston, MA

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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
1d
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Quality Systems Manager
Sudbury, Massachusetts, United States
$145k-$165k/yr OnsiteFull Time
Gentuity
Gentuity: A medical device developing and manufacturing healthcare technology.
7+ YOE3+ MgmtRequires 7+ years in medical devices, 3–5 years supervisory experience, quality systems expertise, ISO 13485 and FDA QSR knowledge, and a bachelor's degree or master's degree; extensive experience may substitute.
Microsoft Word, Microsoft Teams, Microsoft Excel, Microsoft Project, Microsoft Visio, PLM, ERP, MDM
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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
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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.
2mo
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Quality Systems Engineer
Salem, New Hampshire, United States
OnsiteFull Time
TTM Technologies
TTM TechnologiesNASDAQ: TTMI: Manufactures printed circuit boards and radio frequency technology solutions.
8+ YOEMaintain and improve QMS, lead internal/external audits, assess risks, drive corrective actions; Bachelor's degree in engineering/quality/manufacturing or related; 8+ years experience (6+ with Master's); proficiency with Microsoft Office and quality software.
Microsoft Office
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Principal Quality Systems Specialist
Northridge or California or Seattle or Washington or Boston or New York City or Los Angeles County or United States
$121k-$205k/yr OnsiteFull Time
MiniMed Group
MiniMed GroupNasdaq: MMED: A medical device developing insulin delivery systems and connected care solutions for people living with diabetes.
5+ YOEBaccalaureate degree with 7+ years (or advanced degree with 5+ years) in quality systems; experience with QMS, Change Management, CAPA, audits, and Microsoft Office; strong communication and prioritization skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Agile, Trackwise, Microsoft Teams, Microsoft Project, Power BI
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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
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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
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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
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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
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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
2mo
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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
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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
3w
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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
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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
3d
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Software Systems Quality Engineer - Tewksbury, MA
Tewksbury or Andover or Pelham or Marlborough
$69k-$131k/yr OnsiteFull Time
RTX
RTXNYSE: RTX: Provides advanced aerospace and defense systems and services.
2+ YOEBachelor's degree in STEM and 2 years of quality or engineering experience required. Requires U.S. citizenship, active Secret clearance, and experience with quality, software, testing, requirements, defects, releases, metrics, and analysis.
Windchill PDM, Azure DevOps, Microsoft Excel, PowerPoint, Confluence, Azure DevOps Server, Jenkins, GitHub, Coverity, Integrated Development Environment (IDE), ClearCase, DOORS, RQM, Cameo, Rhapsody, Oracle, SAP, LAN, WAN, VPN, OSI, TCP, IP, IPsec, TLS, DHCP, SNMP, FC, SCSI, DNS, IDS, SIEM
2w
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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