3w
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Quality Manager
Indianapolis, Indiana, United States
$110k/yr OnsiteFull Time
10+ YOE5+ Mgmt10+ years quality experience in regulated manufacturing, 5+ years leadership, ISO 13485, CAPA, root cause analysis, SPC, PFMEA, Six Sigma, audit leadership; ITAR U.S. person required.
ISO 13485, CAPA, SPC, PFMEA, 8D
2mo
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Quality Assurance (QA) Supervisor- Tremont
Indianapolis, Indiana, United States
$50k-$60k/yr OnsiteFull Time
QA supervisor leading QMS compliance, ISO audits, CAPA/NCR, document control, and cross-functional collaboration.
MS Office, Visio, G Suite
2mo
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QA Specialist for IQC,1st shift
Fishers, Indiana, United States
OnsiteFull Time
4+ YOEQA specialist with GMP manufacturing, IQC, batch records, deviations, CAPA, and data systems; 4+ years in pharmaceutical QC.
Veeva, SCADA, BMS, CMMS, LIMS, JMP, Minitab, Microsoft Word, Microsoft Excel, Visio
1w
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Principal Scientist Deviation Management Lilly Medicine Foundry
Indianapolis or Lebanon
$65k-$169k/yr OnsiteFull Time
3+ YOEExperience leading deviation/OOS investigations, root cause analysis and CAPA in GMP environments; BS/MS in scientific discipline; strong technical writing and troubleshooting skills.
TrackWise, Veeva QMS, FMEA
2w
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Quality & Compliance Manager onsite in Lebanon, IN- Life Sciences/ Pharmaceutical
Lebanon, Indiana, United States
OnsiteFull Time
3+ YOESupervisory experience with 3+ years relevant experience, knowledge of audits/CAPAs in life sciences/pharmaceutical/GMP, strong leadership, organizational and communication skills, and Microsoft Office proficiency.
Microsoft Word, Microsoft Excel, Microsoft Outlook
4w
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Coordinator-Quality Assurance, Quality and Patient Safety-Path Lab
Indianapolis or Indiana
HybridFull Time
4+ YOEBachelor's in medical technology or related field required, 4 years relevant experience, CAPA and policy/procedure experience, knowledge of lab safety and regulations, audit execution and interpretation skills.
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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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.
1mo
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Quality and Training Specialist
Whiteland, Indiana, United States
OnsiteFull Time
1+ YOE1+ years QA experience in distribution/warehouse; knowledge of ISO/QMS, AIB/GMP/FDA compliance, internal auditing, CAPA, risk assessment, training development/delivery, and Microsoft Office proficiency.
QMS, WMS, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Microsoft Outlook
4w
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Coordinator-Quality Assurance, Quality and Patient Safety-Path Lab
Indianapolis, Indiana, United States
HybridFull Time
4+ YOEBachelor's in medical technology or related science, 4 years relevant lab experience, knowledge of lab safety and CAPA, ability to perform audits and interpret regulatory standards, and experience creating/maintaining policies and procedures.
1mo
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Quality Assurance Manager
Westfield, Indiana, United States
$99k-$199k/yr OnsiteFull Time
8+ YOE3+ MgmtB.S. in engineering (or equivalent), 8+ years in manufacturing-quality roles, 3+ years supervisory experience, strong project management and people leadership, nonconformance/CAPA experience, regulatory compliance, and continuous improvement skills.
1w
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Senior Validation Engineer
Indianapolis, Indiana, United States
$108k-$131k/yr OnsiteFull Time
4+ YOE4-8 years validation experience in GMP radiopharmaceutical or injectable manufacturing; BS/MS in scientific field or equivalent experience; CQV, technical writing, deviation/CAPA support, regulatory knowledge, strong communication.
1w
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Senior Supplier Quality Engineer
Spencer, Indiana, United States
$81k-$154k/yr OnsiteFull Time
5+ YOEBS in engineering/chemistry,5+ years quality engineering in medical device manufacturing,manufacturing process controls,knowledge of QSR/ISO,material/purchasing controls,validation and CAPA,project leadership and supplier performance management.
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.
3mo
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Quality Specialist (Carmel, IN, US)
Carmel, Indiana, United States
RemoteFull Time
6+ YOEBachelor's in Engineering/Science/Technology/Quality/Manufacturing or related; 6+ years in Quality Management Systems in manufacturing; experience with ISO 9001/AS9100/IATF16949/ISO13485; QMS implementation, internal audits, CAPA, and certification support.
Microsoft Office
1w
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Senior Validation Engineer
Indianapolis, Indiana, United States
$108k-$131k/yr OnsiteFull Time
4+ YOEBS/MS or equivalent; 4-8 years validation experience in GMP radiopharmaceutical or injectable manufacturing; strong technical writing, regulatory validation, deviation/CAPA investigation, and ability to work in cleanrooms handling radioactive material.
1mo
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Quality Control Specialist II
Indianapolis, Indiana, United States
$22-$28/hr OnsiteFull Time
2+ YOEAAS required (BA/BS preferred) and minimum 2 years manufacturing quality experience; ability to read technical drawings; perform inspections, process audits, FAI, CAPA, NCR; recommend process improvements and train others.
PC, printer, telephone, fax machine, copier, cutting machine, vacuum chamber, scales, calipers, tape measure, digital camera
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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Quality Assurance Specialist
Indianapolis, Indiana, United States
$60k-$65k/yr OnsiteFull Time
2+ YOEMaintain QMS, perform audits, manage CAPA and root cause analysis, support warehouse quality and inventory accuracy; 2+ years quality/logistics experience preferred; ISO 9001:2015 knowledge; associate/bachelor preferred.
ISO 9001:2015, Microsoft Excel, Microsoft Word
1mo
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Quality Assurance Manager
Westfield, Indiana, United States
$99k-$199k/yr OnsiteFull Time
8+ YOE3+ MgmtB.S. in Engineering or equivalent; 8+ years manufacturing-quality experience with 3+ years supervisory experience; strong project management, CAPA, regulatory compliance, and people leadership skills. Medical device and Six Sigma/ASQ credentials preferred.