15 quality systems specialist jobs at 7 companies in Ware, MA
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Principal Specialist, Supplier Quality and Development (Hybrid)
East Hartford, Connecticut, United States
$87k-$165k/yr HybridFull Time
5+ YOEBachelor's degree in engineering, quality, or a technical discipline plus 5 years of relevant experience, or an advanced degree plus 3 years. Quality systems and aerospace experience preferred.
Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft Access, Microsoft Project, AS9100, ISO 9000, PFMEA, DFMEA, GR&R, GD&T, Six Sigma, Red-X, Lean, CORE, QCPC, DIVE
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
2mo
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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
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
1mo
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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 at manufacturing site) preferred; Bachelor's in STEM preferred; experience with batch record review, deviations, CAPA, and GxP electronic systems; MS Office proficiency.
MES/Syncade, SAP, Infinity, BMSDocs (Veeva), CELabs, ValGenesis, DeltaV, Maximo, Microsoft Office
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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
2mo
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Senior Specialist, Field Quality QA Operations
Devens, Massachusetts, United States
$90k-$108k/yr OnsiteFull Time
4+ YOE4 years QA experience in pharma/medical device, batch record review experience, knowledge of US/EU cGMP, ability to perform on-floor GMP walkthroughs, and familiarity with electronic batch record systems (DeltaV desirable). Bachelor's degree preferred.
DeltaV
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.
3mo
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Senior Complaint Specialist
Bedford, Massachusetts, United States
$84k-$110k/yr OnsiteFull Time
3+ YOELead end-to-end global complaint handling ensuring regulatory compliance (FDA/ISO/EU MDR), investigations, MDR reporting, CAPA, and post-market quality systems.
Microsoft Office, Complaint management system, Quality Management Database, CRM
2mo
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Senior Specialist, Quality Assurance Investigations, Cell Therapy, Devens - MA
Devens, Massachusetts, United States
$90k-$109k/yr OnsiteFull Time
4+ YOE4+ years in a regulated industry with 1+ year deviation experience; Bachelor's in STEM preferred; experience with electronic systems/databases, root cause analysis tools, MS Office and Smartsheet; ability to review/approve investigations and CAPAs.
Microsoft Office, Smartsheet
2mo
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Senior Specialist, Quality Assurance Investigations, Cell Therapy, Devens - MA
Devens, Massachusetts, United States
$90k-$109k/yr OnsiteFull Time
4+ YOE4+ years in a regulated industry with 1+ year deviation experience; ability to review and approve investigations/CAPAs, perform root cause analysis, apply regulatory guidance (FDA/EMA), and use electronic systems (MS Office, Smartsheets). Bachelor's in STEM preferred.
Microsoft Office, Smartsheets
3mo
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QA Compliance Specialist II
Lee, Massachusetts, United States
$65k-$85k/yr OnsiteFull Time
3+ YOE3-5 years in a cGMP environment; QA/Regulatory focus; proficient in MS Office and QA documentation systems; strong attention to detail.
Microsoft Office, Adobe Acrobat, Electronic Quality Management System
1w
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Logistics Inventory Control Specialist
Auburn, Massachusetts, United States
$26-$33/hr OnsiteFull Time
5+ YOEAssociate's degree, 5+ years in logistics, supply chain, manufacturing, or inventory management, advanced SAP, Microsoft Office proficiency, analytical skills, and regulated quality systems knowledge.
SAP, Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft Outlook, Microsoft Visio
2mo
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Advanced Practitioner Clinical Informaticist Specialist
Hartford, Connecticut, United States
OnsiteFull Time
3+ YOEGraduation from an accredited NP or PA program, active CT NP/PA license and DEA, 3+ years PA/NP experience, proficiency with Epic EMR and Tableau, experience in data analysis, system implementation, team leadership, and quality improvement.
Epic EMR, Tableau
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