1mo
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Quality Control Process Engineer (Indianapolis, IN, US, 46202)
Indianapolis, Indiana, United States
$72k-$102k/yr OnsiteFull Time
10+ YOEBachelor’s in Engineering/Science preferred (or Associate's/10+ years experience); quality control experience with root cause analysis (5 Why's, 5W2H), GD&T, CMM, SPC; SAP knowledge a plus; willing to travel up to 13 days/year; U.S. work authorization required.
Coordinate Measurement Machine (CMM), SAP, GD&T, SPC
1mo
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Quality Engineer
Noblesville, Indiana, United States
OnsiteFull Time
Bachelor’s degree in mechanical/technical engineering; experience in quality engineering, process improvement, and documentation; GD&T, SPC, FMEA; ISO 9001; supplier quality management.
2mo
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Principal Analyst, Quality Business Process
Arden Hills or Valencia or Spencer or Marlborough or Quincy or Maple Grove or Coventry
$102k-$194k/yr HybridFull Time
7+ YOEBachelor's in engineering/science, 7+ years in quality/engineering/operations/QA, 3+ years in medical device or regulated industry, business process design and quality systems knowledge; SAP S/4HANA experience preferred.
SAP S/4HANA
2w
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Process Engineer
Indianapolis, Indiana, United States
OnsiteFull Time
Lead process improvement, troubleshoot equipment and processes, ensure safety and quality, work with ERP/CAD/CMMS, bachelor’s degree preferred, hands-on manufacturing experience and leadership ability.
Microsoft Excel, Microsoft PowerPoint, Microsoft Word, Enterprise Resource Planning (ERP), 2D CAD, 3D CAD, Computerized Maintenance Management Systems (CMMS)
3mo
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Quality Engineer II
Indianapolis, Indiana, United States
OnsiteFull Time
3+ YOE3+ years' experience as a Quality Engineer or related role; BS in Mechanical Engineering; ISO/TS16949 experience; corrective action, process audits; strong analytical and communication skills.
GD&T, CMM, SPC, PFMEA, Process Control Plans, 8D, Layered Process Audits
1mo
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Senior Quality Process Validation Specialist
Fishers, Indiana, United States
OnsiteFull Time
5+ YOEBachelor's in science/engineering, 5+ years pharma/CDMO process validation experience, hands-on PPQ and CPV, CPP/CQA identification, statistical process monitoring, familiarity with FDA/EMA/ICH Q8-Q12 and technology transfer, audit support experience.
Minitab, JMP
3w
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Staff Quality Assurance Engineer
Indianapolis, Indiana, United States
OnsiteFull Time
7+ YOE7+ years quality or manufacturing engineering experience in regulated industries; apply ISO 9001/13485 and 21 CFR Part 820; process validation, CAPA, risk management, and continuous improvement; BS in engineering or science required.
Power BI, DAX, Power Query, Oracle, IQVIA, ERP, eQMS
1w
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Senior Supplier Quality Engineer
Spencer, Indiana, United States
$81k-$154k/yr OnsiteFull Time
5+ YOEBachelor in engineering/chemistry or similar,5+ years quality engineering experience in medical device manufacturing, QSR/ISO knowledge, manufacturing process controls, CAPA and validation experience, project leadership and supplier quality expertise.
1w
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Senior Supplier Quality Engineer
Spencer, Indiana, United States
$81k-$154k/yr HybridFull Time
5+ YOEBSc in engineering/chemistry,5+ years quality engineering in medical device manufacturing,manufacturing process controls experience,and knowledge of QSR and ISO material/purchasing controls, validation and CAPA.
2w
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Global Mfg. Quality Engineer-Welding Specialist
Indianapolis, Indiana, United States
RemoteFull Time
3+ YOESTEM degree or equivalent, 3–5 years manufacturing quality experience, welding experience required (laser welding preferred), PFMEA/control plan knowledge, process improvement, significant travel for 12–18 months.
1mo
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Corporate Quality Senior Analyst
Indianapolis or United States or Canada or North America
$89k-$107k/yr HybridFull Time
1+ YOEBachelor's in science/engineering, 1+ years quality systems experience, knowledge of FSMA/FDA 21 CFR, problem-solving/root cause analysis, travel in North America, ability to lead audits and drive food safety programs.
1mo
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Advanced Quality Engineering Manager (Indianapolis, IN, IN, US)
Indianapolis, Indiana, United States
$130k-$150k/yr OnsiteFull Time
8+ YOE8+ MgmtBachelor's in engineering or related field, 8+ years manufacturing quality experience including 8+ years leadership; experience with process development, APQP, new product integration, advanced problem solving, and continuous improvement.
APQP, Built-in Quality (BiQ), LinkedIn Learning
1mo
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Manufacturing Engineer 2
Bloomington, Indiana, United States
OnsiteFull Time
5+ YOEBachelor's in engineering, 5+ years in quality/manufacturing/development engineering, knowledge of medical device regulations and quality tools, experience with process validation, equipment design, and project management preferred.
Quality Management System (QMS)
3mo
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Controls Engineer
Columbus, Indiana, United States
OnsiteFull Time
5+ YOEBachelors in engineering (or 5 years manufacturing engineering experience). Manufacturing/automotive experience, PLC troubleshooting, AutoCAD (electrical/mechanical), Allen-Bradley programming, automation and quality/process improvement experience.
AutoCAD, Allen-Bradley, PLC
1mo
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Manufacturing Engineer - CMC Machining
Indianapolis, Indiana, United States
$91k-$148k/yr HybridFull Time
2+ YOEEngineering degree or equivalent experience, 2+ years engineering experience (varies by degree), U.S. citizen or permanent resident, experience scaling R&D processes to production, knowledge of process validation and quality tools (PFMEA, APQP, PPAP) and automation integration.
CAD, CAM, CAPP, Manufacturing Execution System (MES), Manufacturing Intelligence, SAP
2w
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Principal Technical Operations Engineer (Radiopharmaceuticals)
Indianapolis, Indiana, United States
$81k-$116k/yr OnsiteFull Time
4+ YOELead development and improvement of radiopharmaceutical manufacturing processes, manage NCRs/CAPAs and change controls, ensure compliance with ISO 13485 and 21 CFR 820, and support operations and quality functions.
2mo
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Principal Scientist - Molecular Biology, Cell Culture Upstream Process Development
Indianapolis, Indiana, United States
$65k-$169k/yr OnsiteFull Time
3+ YOEBS/MS in relevant biological or engineering field (BS+6 yrs or MS+3 yrs). Hands-on cell culture and cell line development experience, upstream process development, regulatory and quality compliance, strong communication and teamwork. PhD not considered. Must be authorized to work in the U.S.; no visa sponsorship provided.
3mo
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Senior Calibration Technician
Indianapolis, Indiana, United States
OnsiteFull Time
4+ YOEExtensive calibration experience with process/instrumentation equipment; CMMS experience; up to 75% travel; pharma/quality experience preferred.
CMMS, MAS500, Pivot Table, Project KPI, GxP documentation, FDA guidelines, NIST traceability
1mo
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Aerospace Source Inspector
Mississippi or Indianapolis
FieldMultiple Commitments Available
Perform in-process and final source inspections including AS9102 first article inspections; read complex engineering drawings and GD&T (ANSI/ASME Y14.5); use handheld measuring tools (calipers, micrometer); pass GE quiz; must be U.S. citizen and willing to travel within a 150-mile radius of Indianapolis.
calipers, micrometer