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
2w
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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
3w
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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
1mo
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Manufacturing Engineer 2
Bloomington, Indiana, United States
OnsiteFull Time
5+ YOEBachelor's in engineering, 5+ years in manufacturing/quality engineering, knowledge of medical device regulations, quality tools, project management; experience with validations, CAPAs, NCRs, and supplier interactions.
Quality Management System (QMS)
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.
3w
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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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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.
4d
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Science and Compliance Specialist, Weekend PM
Bloomington, Indiana, United States
OnsiteFull Time
2+ YOEBS preferred or equivalent aseptic manufacturing experience,2+ years technical writing,knowledge of GMP,CAPA,FDA regulations,Veeva and Microsoft Office proficiency,strong problem-solving and communication skills.
Veeva, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook
6d
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Quality Assurance Specialist
Clayton, Indiana, United States
$65k-$80k/yr OnsiteFull Time
3+ YOE3+ years QA experience in GMP-regulated environments; knowledge of FDA 21 CFR (111,210,211), ISO 13485, CAPA, audits, supplier quality; BS preferred; SAP and Microsoft Office proficiency.
SAP, Microsoft Excel, Microsoft Word
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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Senior QA Engineer
Greenwood, Indiana, United States
OnsiteFull Time
5+ YOE2+ MgmtBachelor's in engineering or related field,5+ years QA in manufacturing/distribution,2+ years managing quality staff,experience with ISO 13485/MDSAP/FDA,QMS,CAPA,root-cause methods.
ISO 13485, MDSAP, FDA, A3, 8D, DMAIC
2w
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Coordinator, Computerized Maintenance Management System
Indianapolis, Indiana, United States
$61k-$74k/yr OnsiteFull Time
3+ YOE3+ years maintenance coordination experience in regulated industries, HS diploma preferred, CMMS experience (Maximo, SAP Maintenance, Blue Mountain RAM), familiarity with GMP/EHS/NRC, SOP/CAPA involvement.
Maximo, SAP Maintenance, Blue Mountain RAM, BAS/BMS, CMMS
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.
1mo
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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 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.
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