31 quality systems specialist jobs at 23 companies in Massachusetts
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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
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
Cambridge, Massachusetts, United States
$107k-$139k/yr OnsiteFull Time
5+ YOEBachelor’s degree in life sciences or biopharma with 5+ years of quality systems experience, or 7+ years relevant GLP/GMP experience without a degree; QMS, CAPA, audit, regulatory, analytical, and communication skills required.
Electronic Laboratory Notebook, Quality Management Systems (QMS), CAPA, Microsoft?, Qualio, Veeva, Benchling
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Senior Quality Systems Specialist
Boston, Massachusetts, United States
$95k-$105k/yr OnsiteFull Time
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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Lead Quality Systems Specialist
Lawrence, Massachusetts, United States
$117k-$196k/yr OnsiteFull Time
6+ YOEBachelor's degree, 6+ years related experience, deep knowledge of quality systems, recalls/corrections & removals, regulatory requirements (US, Health Canada, Mexico), Microsoft Access/Outlook/ERP skills, audit and training experience.
Microsoft Access, Microsoft Outlook, ERP software, Microsoft Office
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Senior Specialist or Manager, Quality Systems
Watertown, Massachusetts, United States
$85k-$200k/yr OnsiteFull Time
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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Quality Systems Specialist I, Digital Health
Boston, Massachusetts, United States
$105k-$135k/yr OnsiteFull Time
2+ YOEBachelor's in engineering or life sciences,2+ years QMS/QA experience in medical device or digital health,working knowledge of ISO 13485 and 21 CFR Part 820,QMS processes (CAPA,complaints,audits),and eQMS experience.
eQMS
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Quality Systems and Training Support Specialist
Amesbury, Massachusetts, United States
$57k-$98k/yr OnsiteFull Time
HS/GED required; proficiency with Microsoft Office; experience supporting CMMS, LMS, DMS, NCM/CAPA and calibration databases; records management, report generation, strong written and verbal communication; U.S. citizenship required.
CMMS, LMS, DMS, NCM, CAPA, Microsoft Word, Microsoft Outlook, Microsoft Excel, Microsoft PowerPoint
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North America Service Quality Specialist
Burlington, Massachusetts, United States
$84k-$127k/yr OnsiteFull Time
2+ YOEBachelor's degree and 2+ years of quality management systems experience plus 1+ year of QA experience. Knowledge of ISO 9001, auditing, communication, organization, and time management preferred.
ISO 9001, Quality Management System (QMS)
2d
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North America Service Quality Specialist
Burlington, Massachusetts, United States
$84k-$127k/yr OnsiteFull Time
2+ YOEBachelor's degree, 2+ years of Quality Management Systems experience, and 1+ year of QA experience. ISO 9001, auditing, cGMP, communication, organization, and team-building skills preferred.
Quality Management System (QMS), ISO 9001, LS Audit Standard (040091MP), cGMP, Key Quality Indicators (KQIs)
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North America Service Quality Specialist
Burlington, Massachusetts, United States
$84k-$127k/yr OnsiteFull Time
2+ YOEBachelor's degree, 2+ years of Quality Management Systems experience, 1+ year of QA experience, and knowledge of ISO 9001-based systems. Pharmaceutical and auditing experience preferred.
Quality Management System (QMS), ISO 9001, Key Quality Indicators (KQIs), Integrated Management Reviews
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Quality Assurance Specialist
Mansfield, Massachusetts, United States
$60k-$68k/yr OnsiteFull Time
High school diploma/GED, exceptional attention to detail, process-oriented, proficiency in Microsoft Word and Excel, familiarity with ASME and Oracle systems preferred, legal US work authorization required.
Microsoft Word, Microsoft Excel, Oracle
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Principal Clinical Quality Assurance Specialist
Maple Grove or Arden Hills or Marlborough
$117k-$222k/yr HybridFull Time
5+ YOEBachelor's degree, 5+ years clinical QA experience including GCP audits, working knowledge of ISO 14155/13485/GCP/GMP/GDP, CAPA and quality systems experience, ability to travel up to 30%.
ISO 14155, ISO 13485, Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Documentation Practice (GDP)
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Quality Assurance Specialist
Boston, Massachusetts, United States
$99k-$109k/yr OnsiteFull Time
Experience in cell processing quality systems, auditing, regulatory compliance (FACT, FDA, JCAHO, AABB, CLIA), proficiency with databases and spreadsheets, strong analytical and communication skills.
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Senior Specialist, Field Quality QA Operations
Devens, Massachusetts, United States
$90k-$108k/yr OnsiteFull Time
4+ YOEMinimum 4 years QA experience in pharmaceutical or medical device manufacturing, batch record review experience, knowledge of US/EU cGMP, familiarity with electronic/paper batch record systems and DeltaV; bachelor's degree preferred.
DeltaV
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Senior Quality Training Specialist
Waltham, Massachusetts, United States
$119k-$145k/yr HybridFull Time
8+ YOEBachelor's degree and 8+ years in pharmaceutical or biotechnology Quality, Quality Systems, training, or related work. Requires GxP, QMS, LMS, adult-learning, facilitation, compliance, and analytical skills.
Quality Management System (QMS), Learning Management System (LMS), GxP
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Specialist, Quality Assurance Shop Floor, Cell Therapy
Devens, Massachusetts, United States
$40-$49/hr OnsiteFull Time
2+ YOE2+ years cGMP experience (1+ year site manufacturing), ability to provide on‑the‑floor QA oversight, review batch records and deviations, support inspections, work in cleanroom environments, and use MES/SAP/Veeva systems.
MES/Syncade, SAP, Infinity, BMSDocs (Veeva), CELabs, ValGenesis, DeltaV, Maximo, Microsoft Office
6d
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Senior Clinical Research Quality and Compliance Specialist
United States or San Francisco or Massachusetts or Los Angeles County
$161k-$218k/yr RemoteFull Time
12+ YOERequires a bachelor's degree with 12+ years, master's with 10+ years, or PhD with 6+ years relevant FDA-regulated clinical research experience, including IND trials, quality systems, audits, CAPA, and ICH GCP.
Investigational New Drug (IND), 21 CFR Part 312, ICH GCP, Chemistry, Manufacturing, and Controls (CMC), electronic Trial Master File (eTMF)
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Principal Clinical Quality Assurance Specialist
Marlborough, Massachusetts, United States
$117k-$222k/yr HybridFull Time
5+ YOEBachelor's degree in science/engineering/health-related field, 5+ years clinical QA or clinical research compliance experience, 5+ years conducting GCP/regulatory audits, knowledge of ISO 14155/13485/GCP/GMP/GDP, CAPA and quality systems experience.
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Data Quality & Service Design Specialist
Boston, Massachusetts, United States
$72k-$104k/yr HybridFull Time
3+ YOEMinimum 3 years EDP experience including 1 year systems analysis; ability to collect user requirements, write specs and test plans; familiarity with SaaS, workforce development programs, federal/state reporting, and testing/documentation.
SaaS, CRM, analytics platforms, Microsoft Office, SharePoint, Teams
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Senior Compliance Specialist
Hopkinton, Massachusetts, United States
$80k-$110k/yr OnsiteFull Time
5+ YOEBachelor's degree with 8+ years or master's degree with 5+ years of relevant experience, plus 5+ years leading GMP quality systems, deviations, investigations, CAPAs, and change controls.
Ishikawa, 5 Whys, 6Ms, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, electronic Quality Management Systems (eQMS), FMEA, FASEP, Lean Six Sigma
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