213 capa jobs at 120 companies in Shrewsbury, MA
4d
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CAPA Facilitator Associate
Newark or Marlborough
$78k-$122k/yr OnsiteFull Time
Experience in quality assurance, quality systems, CAPA, root cause analysis, audits, data analysis, KPIs, procedures, training materials, and regulated industries; strong communication and independent judgment required.
Quality Management Systems (QMS), Corrective and Preventive Action (CAPA), Quality Plans (QPLs), Key Performance Indicators (KPIs)
2mo
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QA CAPA Engineer II
Bedford, Massachusetts, United States
$66k-$88k/yr OnsiteFull Time
2+ YOE2+ years quality or manufacturing experience in a regulated industry; BS preferred; perform RCA, implement CAPAs, statistical analysis, knowledge of ISO 13485/21 CFR 820; strong communication and Microsoft Office skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Minitab, JMP, TrackWise CAPA Management System
2mo
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Senior Quality Systems Engineer- CAPA/Complaints Support - Medical Device #8161
Boston, Massachusetts, United States
OnsiteContract, Full Time
5+ YOE5+ years medical device experience, Bachelor’s in biomedical/mechanical/electrical engineering required, experience executing CAPA, regulatory knowledge for Class II/III devices, strong analytical and problem-solving skills.
3mo
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Quality Engineer
Waltham, Massachusetts, United States
$102k-$166k/yr HybridFull Time
5+ YOEQuality engineer with data analytics experience; supplier, manufacturing, and design quality focus; CAPA and PPAP familiarity; cross-functional collaboration.
Salesforce, Arena PLM, Statistical Analysis, CAPA, PPAP
2mo
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Senior Supplier Quality Engineer
Manchester, New Hampshire, United States
OnsiteFull Time
3+ YOEBachelor's in engineering/l life sciences; 3-5 years supplier quality in medical devices; ISO 13485 knowledge; experience with supplier audits, NPI, and CAPA.
ISO 13485, CAD, FMEA, CAPA, Statistical Tools
3w
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Design and Sustaining Quality Engineer
Clinton, Massachusetts, United States
$110k-$198k/yr OnsiteFull Time
8+ YOEBachelor's degree in engineering or equivalent experience, 8+ years in medical device quality or manufacturing engineering, Microsoft Office proficiency, data analysis, CAPA, and cross-functional leadership.
Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Power BI, Tableau, Looker, Pivot tables, Pivot charts, Six Sigma, DMADV, DMAIC, CAPA, ISO 13485
3d
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Senior Quality Assurance Engineer
North Billerica, Massachusetts, United States
$120k-$140k/yr OnsiteFull Time
4+ YOEBachelor of Science in engineering or science, 4+ years in OEM medical device manufacturing, and knowledge of GMP, FDA regulations, ISO 13485, quality systems, CAPA, and electronic documentation.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, electronic document management systems, 21 CFR Part 820, ISO 13485, IVDR, GMP, CAPA, FMEA
2d
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Program Service Specialist - Deviation Management
Cumberland, Rhode Island, United States
$64k-$68k/yr HybridFull Time
2+ YOEBachelor's degree in a scientific discipline, 2+ years in quality assurance or related work, product quality investigation experience, root cause and CAPA knowledge, technical writing, and regulatory expertise.
CAPA, Certificates of Analysis (COAs)
3d
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Director of Quality
Jaffrey, New Hampshire, United States
$155k-$290k/yr OnsiteFull Time
8+ YOEBachelor’s degree and 8+ years of quality management experience in regulated manufacturing. Requires leadership, quality systems, risk management, CAPA, audits, supplier quality, and regulatory compliance expertise.
ISO 9001, ICH Q9, CAPA, FTIR, DSC, Microsoft Office, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Teams, Microsoft SharePoint, ERP, FMEA, SPC
1w
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Quality Engineer – Product Quality & EHS
Westborough, Massachusetts, United States
OnsiteFull Time
3+ YOEBachelor's in engineering, 3+ years quality engineering in manufacturing, knowledge of ISO/IATF standards, SPC/MSA/FMEA/APQP/PPAP/8D/CAPA, strong analytical and project skills.
SPC, MSA, FMEA, APQP, PPAP, 8D, CAPA, Microsoft Office, quality management systems
1mo
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Customer Quality Engineer II
Beverly, Massachusetts, United States
$79k-$118k/yr OnsiteFull Time
3+ YOEBachelor's in engineering or related field, 3+ years quality experience in semiconductor or high-tech manufacturing, knowledge of 8D/RCA/FMEA/SPC/CAPA and ISO 9001, strong communication and analytical skills.
8D, RCA, FMEA, SPC, CAPA, Lean, Six Sigma, APQP, QMS, ISO 9001
1w
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Associate Director, Clinical Study Quality Lead (Hybrid)
Boston, Massachusetts, United States
$161k-$241k/yr HybridFull Time
8+ YOEBachelor's degree in a scientific or allied health field and 8+ years of relevant experience; expertise in ICH-GCP, global regulations, clinical trials, quality risk management, CAPA, metrics, and Microsoft Office.
Microsoft Office, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Smartsheet, Visio, CAPA, ICH-GCP, FDA, EMA, MHRA
1mo
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Quality Engineering Technician
East Providence or Sanford or Phoenix
OnsiteFull Time
Experience in quality or manufacturing roles, familiarity with ISO 9001/AS9100, NC/CAPA processes, document control, audit support, Excel/ERP proficiency, strong written/verbal communication and attention to detail.
Microsoft Excel, Microsoft Office, ERP, FMEA, CAPA, IPC standards
1w
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Quality Systems Engineer III
Indianapolis or Plainfield or Quincy
$82k-$156k/yr RemoteFull Time
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
1w
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Quality Systems Engineer III
Indianapolis or Plainfield or Quincy
$82k-$156k/yr RemoteFull Time
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
1w
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Senior Quality Manager-Advanced Imaging
Bedford, Massachusetts, United States
$134k-$213k/yr HybridFull Time
8+ YOERequires 8+ years in FDA-regulated medical device environments, quality management and design assurance leadership, medical device regulatory knowledge, CAPA and audit experience, and a bachelor's degree in quality, engineering, or a related discipline.
FDA QMSR, ISO 13485, European Medical Device Regulation (MDR), ISO 14971, 21CFR, MDD, GMP, GDP, DFMEA, PFMEA, CAPA, Lean, Six Sigma, HSA
1w
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Manager, Pharmacovigilance Case Processing
Boston or France
$131k-$150k/yr HybridFull Time
4+ YOEBachelor's degree in life science or PharmD, 4+ years of pharmacovigilance case management, global safety database experience, PV regulations knowledge, quality control, CAPA, KPI monitoring, vendor oversight, and audit expertise.
ARGUS, electronic case report forms (eCRFs), Safety Management Plans (SMP), Safety Data Exchange Agreements (SDEA), CAPA, KPI
1mo
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Manager, Clinical Post Market Surveillance
Burlington, Massachusetts, United States
$99k-$199k/yr OnsiteFull Time
3+ MgmtBachelor's in biomedical engineering, nursing or related (or equivalent experience). 3+ years managing a team. Knowledge of domestic/international medical device regulations, risk assessment, CAPA and audit management, and advanced analytical and PC skills.
Quality Management System, CAPA System, External Requirements Management System, spreadsheets, word processing, database management, project management applications
2w
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Manufacturing Quality Engineer IV - Clean Energy
South Portland or Waukesha or North Billerica or Reno
$121k-$180k/yr OnsiteFull Time
8+ YOE8+ years manufacturing quality experience in high-reliability electronic/electromechanical products, bachelor\u0002s in engineering, experience with PPAP/8D/CAPA/SCAR, solder and PCB processes, strong quantitative and problem-solving skills.
DFMEA, DFM, PFMEA, Control Plans, PPAP, 8D, CAPA, SCAR, Gage R&R, CPK
2mo
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Engineer Process Development Environmental & Contamination Control
West Greenwich, Rhode Island, United States
$88k-$119k/yr OnsiteFull Time
2+ YOEEducation plus engineering/operations experience (options: HS+8yrs, Associate+6yrs, Bachelor+2yrs, or Master). Prefer 2+ years pharma/biopharma cGMP experience, strong communication, and experience with EBR/DeltaV/CAPA.
EBR, DeltaV, CAPA