211 capa jobs at 114 companies in Peabody, MA
17h
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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.
1mo
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Quality Systems Engineer – CAPA and Process Improvement
Manchester, New Hampshire, United States
OnsiteFull Time
3+ YOEBS/MS in engineering, life sciences, or related field; 3+ years in quality systems in a regulated industry (medical device preferred); working knowledge of FDA QSR (21 CFR Part 820) and ISO 13485; strong technical writing and communication; proficiency with Microsoft Excel, Word, and Visio.
Microsoft Excel, Microsoft Word, Microsoft Visio
2mo
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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
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
6d
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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
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
3w
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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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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
2w
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Senior Director Quality
Portsmouth or Minneapolis
OnsiteFull Time
12+ YOE5+ Mgmt12+ years quality leadership in medical devices, 5+ years managing quality organizations; experience with product/manufacturing quality, CAPA, FDA QSR, ISO 13485, ISO 14971, audits, and continuous improvement.
ISO 14971, ISO 13485, FDA Quality System Regulation (QSR), CAPA, Lean, Six Sigma
6d
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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
1mo
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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
1mo
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Quality Engineer
Randolph, Massachusetts, United States
OnsiteFull Time
3+ YOEBachelor's in engineering, 3+ years quality or manufacturing engineering experience, strong QMS knowledge, root cause analysis (8D, 5 Why, Fishbone, FMEA), CAPA, SPC/MSA, ability to read drawings, and strong communication.
QMS, 8D, 5 Why, Fishbone, FMEA, CAPA, SPC, MSA, ISO 9001
2w
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Green Hydrogen Quality Engineer
Burlington, Massachusetts, United States
$110k-$160k/yr OnsiteFull Time
3+ YOEBachelor's in materials or mechanical engineering,3–7 years quality engineering in manufacturing, practical command of FMEA, SPC, MSA/Gage R&R, 8D/CAPA, ISO 9001 QMS experience, strong communication skills.
FMEA, SPC, DOE, MSA/Gage R&R, 8D, CAPA, APQP, PPAP, Design of Experiments (DOE), Six Sigma, ISO 9001, ISO 22734, IEC 62282, NFPA 2
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