14 capa jobs at 11 companies in Elkhart, IN
1d
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Laboratory Supervisor, MQSA
Warsaw, Indiana, United States
OnsiteFull Time
8+ YOE3+ MgmtBachelor's degree in a scientific discipline, 8+ years of microbiology laboratory experience, 3+ years supervising laboratories, ISO 13485 experience, audit support, technical testing, equipment qualification, and CAPA management.
MALDI-TOF, Total Organic Carbon (TOC), Laboratory Information Management Systems (LIMS), ISO 13485, ISO 14644, ISO 11137, ISO 17664, AAMI ST98, ASTM, USP, FDA Quality System Regulation, GMP, CAPA, SOPs, IQ, OQ, PQ
1mo
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Quality Engineer I
Warsaw, Indiana, United States
OnsiteFull Time
4+ YOEBachelor's in engineering or 4+ years medical device experience plus ASQ CQE/CMQ-QE; knowledge of FDA/ISO/GMP, FMEA, PPAP, CAPA, statistical methods, and audit participation.
Microsoft Word, Microsoft Excel, Microsoft Outlook, Microsoft PowerPoint, Minitab
2w
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Process Engineer (11463)
Warsaw, Indiana, United States
OnsiteFull Time
0+ YOEB.Eng in engineering or equivalent plus up to 3 years medical device manufacturing experience; knowledge of process validation, CAPA, PFMEA, SPC, and regulatory requirements; strong statistical and project skills.
ERP, Manufacturing Executiron Systems (MES), Minitab, CAD, Microsoft Office, document management systems
1w
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Manager of Quality, Testing & Continuous Improvement
South Bend, Indiana, United States
OnsiteFull Time
5+ YOE2+ MgmtBachelor's in engineering/quality/operations,5+ years quality experience with 2+ years leadership, experience with ISO certifications, RCA/CAPA, calibration/MSA, NPI support, and data-driven CI methodologies.
2w
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Senior Specialist / Principal Specialist, Investigation
Saint Joseph, Michigan, United States
OnsiteFull Time
3+ YOEDegree in a scientific discipline plus relevant years of experience (BS+8, MS+5, PhD+3). Requires investigation, root cause analysis, CAPA, technical writing, regulatory knowledge, and attention to detail.
Microsoft suite, SAP, IDEA for CON, Learning One Source, TrackWise
2mo
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Quality Systems & Compliance Lead
Walkerton, Indiana, United States
OnsiteFull Time
7+ YOESenior QMS role requiring 7+ years in quality systems or manufacturing quality, ownership of eQMS (1factory), ISO 9001/13485 compliance, audit leadership, CAPA management, and ability to translate requirements into manufacturing processes.
1factory
2w
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Quality Engineer
Elkhart, Indiana, United States
OnsiteFull Time
Bachelor's in engineering or science (or 5+ years quality experience); 1-3 years quality/CI experience preferred; knowledge of QMS/CAPA, cGMP, SPC; skilled in root cause analysis and Lean/Six Sigma methods.
Minitab, Microsoft Excel
2w
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Quality Manager - Ready to Eat
Middlebury, Indiana, United States
OnsiteFull Time
5+ YOEBachelor's degree or equivalent experience; 5+ years quality leadership in food manufacturing; expertise in food safety plans, GMPs, sanitation, environmental monitoring, audits, CAPA, traceability, and recall readiness; HACCP, PCQI, SQF required.
3w
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Quality Engineer I - Warsaw
Warsaw, Indiana, United States
OnsiteFull Time
4+ YOEEnsure quality system compliance, support MRB/RMA, prepare FMEAs, control/quality/PPAP plans, investigate complaints and lead CAPA, apply statistical/Six Sigma methods; manufacturing and FDA/ISO knowledge required.
Microsoft Word, Microsoft Excel, Microsoft Outlook, Microsoft PowerPoint, Minitab
1mo
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Quality Associate II - QMS
South Bend, Indiana, United States
OnsiteFull Time
3+ YOEBachelor's in a science field, 3+ years quality experience with medical device/IVD, knowledge of ISO 13485/9001/14971 and FDA QMSR (21 CFR 820), CAPA and audit experience, strong analytical and Microsoft Office skills.
Microsoft Word, Microsoft Excel, Microsoft Outlook
1d
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Supplier Quality Engineer
Plymouth, Indiana, United States
RemoteFull Time
2+ YOESupplier quality expertise, root cause analysis, audits, SCARs, CAPA, supplier risk assessment, technical documentation, project management, Microsoft Office, and quality management systems; 2+ years quality engineering or preferred associate degree.
Bamboo Path Track, Litmos, Microsoft Office, quality management systems
1mo
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Product Design Quality Sr Specialist I (11225)
Warsaw, Indiana, United States
OnsiteFull Time
3+ YOE3-5+ years quality engineering experience in medical devices, B.S. in engineering or related field, knowledge of FDA 21 CFR Part 820/ISO 13485/EU MDR, risk management (ISO 14971/FMEA), V&V, CAPA, and technical documentation.
Windchill, Codebeamer, Jira, Microsoft Office, Minitab, Github
5d
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Continuous Improvement Director
Bristol or South Bend
OnsiteFull Time
10+ YOE10+ MgmtBachelor's degree in engineering, operations, business, or related field; 10+ years in manufacturing leadership and 3+ years building continuous improvement skills. Lean, Six Sigma, Kaizen, analytics, and project leadership required.
Lean, Six Sigma, Kaizen, value-stream mapping, root cause analyses (RCA), corrective and preventive actions (CAPA), ERP, Power BI, Minitab, X-Matrix
1d
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Laboratory Supervisor, MQSA
Warsaw, Indiana, United States
OnsiteFull Time
8+ YOE3+ MgmtBachelor's degree in a scientific discipline, 8+ years of microbiology laboratory experience, 3+ years supervising or managing laboratories, ISO 13485 experience, and regulatory audit support.
MALDI-TOF, Total Organic Carbon (TOC), Laboratory Information Management Systems (LIMS), IQ, OQ, PQ, SOPs, CAPA, ISO 13485, ISO 14644, ISO 11137, ISO 17664, AAMI ST98, ASTM, USP, FDA Quality System Regulation, GMP