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
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
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
1mo
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RN / POST - OP
Seymour, Indiana, United States
$30/hr OnsiteFull Time
Graduation from an accredited nursing program; active Indiana RN licensure and CPR required; CPAN/CAPA preferred; clinical experience required, 1-2 years preferred; familiarity with computerized documentation.
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.
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.
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
2w
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Manufacturing Quality Assurance (QA) Supervisor- 38th and Sheridan
Indianapolis, Indiana, United States
$50k-$60k/yr OnsiteFull Time
Supervise QA staff and QMS operations aligned with ISO 9001/13485, lead audits, manage CAPA/NCR and complaint investigations, use data to drive improvements, and perform moderate-to-hard physical tasks; minimum age 18.
Microsoft Word, Microsoft Excel, Microsoft Outlook, Microsoft PowerPoint, Microsoft Visio, G Suite
4d
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Associate Director, Quality Operations
Bloomington, Indiana, United States
OnsiteFull Time
8+ YOE5+ MgmtBachelor's in life science required; minimum 8 years quality/pharmaceutical experience with 5 years management; cGMP expertise, QA oversight, deviation/CAPA leadership, batch disposition, inspection readiness, and Microsoft/JDE/Trackwise proficiency.
Microsoft Word, Microsoft Excel, Microsoft Outlook, JDE, BPLM, Pilgrim, Trackwise
2mo
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Quality Manager - Life Science Division
Easton or Whiteland
OnsiteFull Time
7+ YOELead quality for life-science warehouse and distribution operations, ensure GxP compliance, manage audits and CAPA, oversee quality personnel, drive risk management and training; 7+ years pharmaceutical/life science quality experience; Bachelor's preferred.
1mo
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Supplier Quality Engineer 2
Bloomington, Indiana, United States
OnsiteFull Time
4+ YOEB.S. in engineering or science; ~4+ years quality experience with ISO 13485/14971, EU MDR, and FDA QSR (21 CFR 820/11); supplier auditing, validation, CAPA, and statistics knowledge; ISO lead auditor credential preferred/required.
1mo
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Engineer, NPI
San Jose or Carlsbad or Wilmington or Indianapolis or Cartago
$87k-$116k/yr OnsiteFull Time
3+ YOEBachelor's in Mechanical/Electrical/Industrial Engineering with 5 yrs experience or Master's with 3 yrs; 3+ yrs SolidWorks and BOM setup (Arena), 2+ yrs Jira/Smartsheet, DFx, VSM, fixture design, and pilot build experience.
SolidWorks, Product Data Management (PDM), Arena, Jira, Smartsheet, Value Stream Mapping (VSM), Kanban, Root Cause Analysis (RCA), Engineering Change Orders (ECO), Non-Conformance Report (NCR), Return Material Authorization (RMA), Corrective and Preventive Action (CAPA)
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