39 quality systems specialist jobs at 23 companies in Danvers, MA
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Quality Systems Specialist - CAPA
Manchester, New Hampshire, United States
OnsiteFull Time
2+ YOEAssociate or bachelor's degree preferred; 2–5 years in quality systems, quality assurance, or a regulated industry. Requires CAPA experience, ISO 13485 and FDA QSR knowledge, root cause analysis, and Microsoft Office proficiency.
Microsoft Office, electronic QMS systems, 5-Why, Fishbone, fault tree analysis
2mo
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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
1w
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Senior Quality Systems Specialist
Cambridge, Massachusetts, United States
$107k-$139k/yr OnsiteFull Time
eGenesis: Developing genetically engineered animal organs for human transplantation.
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
2mo
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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
2w
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Quality Systems Specialist I
Lowell, Massachusetts, United States
$70k-$80k/yr OnsiteFull Time
Associate of Science in manufacturing, engineering, or a technical field, or equivalent experience; GMP/ISO knowledge; data analysis, Microsoft Office, fluent English, and cross-functional teamwork skills.
Microsoft Office, Microsoft Outlook, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, GMP, ISO
2mo
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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
2mo
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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
3w
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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
2mo
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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
1w
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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)
1w
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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
1mo
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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
3w
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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)
1mo
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Senior Specialist, Quality Assurance Laboratory Operations
Devens, Massachusetts, United States
$90k-$109k/yr OnsiteFull Time
4+ YOE4+ years cGMP experience, ability to interpret SOPs/regulations, strong written/verbal skills, data interpretation, experience with quality management systems and GxP electronic systems; Bachelor's in STEM preferred.
BMSDocs, CELabs, MES, SAP, ValG, DeltaV, Maximo, Infinity, Microsoft Power Automate, Smartsheet, Tableau, Microsoft Office
1mo
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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.
1w
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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
1mo
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Senior Specialist, Quality Assurance Laboratory Operations
Devens, Massachusetts, United States
$90k-$109k/yr OnsiteFull Time
4+ YOE4+ years cGMP experience (1+ year site manufacturing preferred). Bachelor's in STEM preferred (HS/Associates with experience considered). Proficiency with quality systems, data interpretation, MS Office and digital tools; strong communication and decision-making skills.
BMSDocs, CELabs, MES, SAP, ValG, DeltaV, Maximo, Infinity, Microsoft Power Automate, Smartsheet, Tableau, MS Office
3mo
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Computer Systems Validation Specialist III
Portsmouth, New Hampshire, United States
OnsiteFull Time
3+ YOEBachelor's in computer science or engineering; 3+ years CSV experience; 3+ years in a cGMP facility; experience with 21 CFR Part 11 and ISPE GAMP; background in biotech/pharma/medical devices; ability to work on-site in Portsmouth, NH.
QMS software, Documentation tools
1w
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QA Specialist II - Ops Floor Support
Bedford, New Hampshire, United States
OnsiteFull Time
3+ YOEBachelor's degree in a relevant scientific field and 3+ years of relevant GMP industry experience, including 1+ year in Quality, or equivalent experience. Requires investigations, technical writing, and quality systems experience.
FMEA, HACCP, PHA, ICH Q9
3w
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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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