12 capa jobs at 10 companies in Fort Wayne, IN
2w
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CAPA Specialist, Analytical Lab - Sturgis, MI Plant
Sturgis, Michigan, United States
$61k-$123k/yr OnsiteFull Time
2+ YOE2+ years CAPA or regulated manufacturing experience, able to progress investigations, apply root-cause analysis, manage CAPA actions, strong attention to detail, project management and communication skills.
3mo
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Director of Supplier Quality
Fort Wayne, Indiana, United States
$153k-$261k/yr OnsiteFull Time
10+ YOEBachelor’s in technical field (or 14+ years experience), 10+ years quality experience in regulated industries, strong knowledge of SPC, APQP/PFMEA/Control Plans, root-cause analysis, supplier audits, CAPA, and leadership skills.
statistical process control, APQP, PFMEA, Control Plans, RCCA, CAPA, SCARs, AS9100, AS9102, AS9145, Lean Six Sigma
1mo
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Director, Quality
Nappanee, Indiana, United States
OnsiteFull Time
10+ YOE5+ MgmtBachelor's in engineering/quality/manufacturing required; 10+ years quality experience with 5+ years leadership; proven QMS and audit experience; expertise in APQP, PPAP, FMEA, SPC, CAPA, Lean, Six Sigma; ASQ and Six Sigma certifications preferred.
Quality Management System (QMS), APQP, PPAP, FMEA, SPC, CAPA, Lean, Six Sigma
2w
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Customer Claims Analyst
Van Wert or Reynosa
OnsiteFull Time
Experience in quality or customer-claims handling in manufacturing; knowledge of Salesforce, SAP/QEHS, CAPA/8D, and customer portals; strong analytical and communication skills; English proficiency.
Salesforce, SAP/QEHS
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
1w
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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
2w
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Quality Assurance Coordinator
Defiance, Ohio, United States
OnsiteFull Time
1+ YOESupport quality systems for FDA 21 CFR 117 and GFSI standards, perform audits, CAPA investigations, root-cause analysis, and support commercialization; 1+ years in food/supplement industry and team leadership experience.
ERP, LIMS
2w
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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
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.
2w
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Quality Engineer II
Hicksville, Ohio, United States
OnsiteFull Time
2+ YOETranslate customer and regulatory requirements into site quality plans, perform MSA/gage R&R, lead root cause/CAPA, use SPC to analyze quality, author QMS docs and lead audits. Bachelor's in engineering or equivalent and 2+ years quality experience.
SPC, FMEA, MSA, gage R&R
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
1d
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Process Technician
Van Wert, Ohio, United States
OnsiteFull Time
3+ YOERequires an associate degree or equivalent manufacturing experience, 3+ years in high-volume manufacturing, process controls, equipment troubleshooting, production data analysis, root cause analysis, and Microsoft Office proficiency.
Microsoft Office, 5 Why, Fishbone, A3 problem solving, CAPA, Kaizen, Management Operating System (MOS), Six Sigma, SPC, PLC, ERP, MES