1mo
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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
1mo
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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
2w
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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
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
4d
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Quality Engineer II
Danvers, Massachusetts, United States
$79k-$119k/yr OnsiteFull Time
2+ YOEBachelor's degree plus 2 years relevant experience (or advanced degree), experience in regulated manufacturing, knowledge of design control, validation, CAPA, FMEA, Six Sigma, DOE, strong analytical and communication skills.
FMEA, Six Sigma, DOE, CAPA
3w
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Sr. Electronics Manufacturing Engineer
Danvers, Massachusetts, United States
$94k-$152k/yr OnsiteFull Time
4+ YOEBachelor's in engineering, minimum 4 years manufacturing engineering in a regulated industry, experience with yield improvement, CAPA, IQ/OQ/PQ, Lean/Six Sigma, product introductions, and strong problem-solving skills.
CAPA, IQ/OQ/PQ, Robotic Automation, Good Manufacturing Practices (GMP), Lean Manufacturing, Six Sigma
1w
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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
2mo
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Associate Director, Clinical Quality and Continuous Improvement
Cambridge or United States
$165k-$223k/yr RemoteFull Time
8+ YOEBachelor's in life sciences required; 8+ years in GCP Quality Assurance/Clinical Quality; experience with process improvement (DMAIC/Lean), RCA, CAPA, inspection readiness, quality metrics, and cross-functional influence.
DMAIC, Lean, Change Management, CAPA, ICH GCP
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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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
5d
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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
5d
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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
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
3w
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Lead Engineer - Analytical Equipment Validation
Portsmouth, New Hampshire, United States
OnsiteFull Time
5+ YOEBachelor's degree required, 5+ years Computer Systems Validation (CSV) experience, knowledge of 21 CFR Part 11/ICH Q7A/GAMP, QMS processes (Change Control, Deviation, CAPA), strong written and oral communication.
21 CFR Part 11, ICH Q7A, GAMP, QMS, CAPA
4d
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Quality Engineer 3
Marlborough, Massachusetts, United States
$85k-$133k/yr OnsiteFull Time
7+ YOEBachelor's degree or equivalent,7+ years medical device quality experience,knowledge of ISO 13485,ISO 14971,FDA and EU MDR/IVDR,cAPA,CAPA,PFMEA,validation and risk management;ASQ CQE or Six Sigma preferred.
ISO 13485, ISO 14971, EU MDR, IVDR, cGMP, Six Sigma, SPC, DOE
2mo
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Sr. Quality Engineer
Lowell, Massachusetts, United States
$100k-$130k/yr OnsiteFull Time
5+ YOEBachelor’s degree in STEM with 5 years of quality engineering experience; knowledge of QA systems, statistics, CAPA, and GMP.
Minitab, Microsoft Excel, Microsoft Office
2mo
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Final Release Specialist II - 2nd Shift
Devens, Massachusetts, United States
$23-$31/hr OnsiteFull Time
3+ YOE3+ years in medical device manufacturing with Final Release/Document Control; read blueprints; review DHRs/Batch Records; manage nonconformances and CAPAs.
ERP, QMS