107 fda jobs at 54 companies in Carmel, IN
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
1w
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Assembler II
Noblesville, Indiana, United States
$22/hr OnsiteFull Time
1+ YOEMinimum ~1 year manufacturing experience preferred; perform brazing, leak testing/charging, wiring, foaming, final test, and sheet metal assembly; follow FDA GMP and DHR procedures; train new employees; comply with safety and attendance policies.
basic hand tools, Device History Records (DHR), FDA GMP
2mo
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Quality Supervisor, Life Science Division 2nd shift
Whitestown, Indiana, United States
OnsiteFull Time
3+ YOELead quality team in raw material sampling; ensure GMP/FDA compliance; manage quality systems and audits; drive continuous improvement.
LIMS, Raman, Calipers, Go/No Go gauges, Microsoft Office
3mo
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Medical Screener (Indianapolis, IN, US, 46241)
Indianapolis, Indiana, United States
OnsiteFull Time
1+ YOEHigh school diploma; 1+ year customer service; Louisiana Clinical Laboratory Personnel license; flexible hours; familiar with FDA, cGMP, OSHA a plus.
NDDR, CDCS, Vital signs equipment
3w
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EMT-P
Kokomo, Indiana, United States
$24-$33/hr OnsitePart Time
2+ YOECurrent EMT-Paramedic in-state credential, CPR/AED, IV therapy capability, FDA-approved BioLife training, and 2 years clinical/hospital experience.
1w
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Production Operator, 1st Shift
Indianapolis, Indiana, United States
OnsiteFull Time
Assemble, test, and package medical and electronic devices per procedures; attention to detail, good documentation, ability to stand/lift, and follow ISO/FDA quality requirements.
ERP
2w
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QA TECHNICIAN 1
Mooresville, Indiana, United States
$20/hr OnsiteFull Time
High school diploma, familiarity with cGMP/FDA/OTC standards, batch record review and release experience, strong attention to detail, communication, and eQMS/ERP proficiency.
Microsoft Office Suite, Red Prairie, SAP, AS400, Dynamic 365, Oracle, Intelex, MasterControl, Harford, LIMS, Labware, Specright
2w
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Production Manager
Fishers, Indiana, United States
OnsiteFull Time
Plan and control medical-grade injection molding and automated assembly production, ensure ISO/FDA/GMP compliance, lead continuous improvement, and supervise production staff.
ERP, MRP, Microsoft Office
3w
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Environmental Health and Safety Specialist
Brownsburg, Indiana, United States
OnsiteFull Time
1+ YOESupport EHS for radiopharmaceutical manufacturing ensuring compliance with NRC, FDA, DOT, OSHA, EPA; perform radiation safety, inspections, incident investigations, training, and records management.
2w
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Process Engineer 2
Indianapolis, Indiana, United States
$67k-$101k/yr OnsiteFull Time
4+ YOEBachelor's in life science or engineering, 4+ years pharmaceutical operations experience, knowledge of US/EU GMP and FDA, project management, process investigations, and equipment design.
Microsoft Visio, AutoCAD, Minitab, JMP, Microsoft Suite, Kepner-Tregoe, FMEA, PLC
1mo
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Quality Specialist - Dry Sweeteners
Indianapolis, Indiana, United States
OnsiteFull Time
Heartland Food Products Group: Produces and markets low-calorie sweeteners and cold brew coffee.
1+ YOEBS degree, 1+ years food manufacturing QA experience, HACCP preferred, SQF and FDA knowledge, strong QA/cGMP skills, documentation and corrective action experience.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint
2w
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Center Operations Manager 2
Indianapolis, Indiana, United States
OnsiteFull Time
1+ YOE1+ MgmtManage daily donor center operations, ensure regulatory compliance (FDA/OSHA/CLIA/GMP), lead quality improvement, supervise staff, and support fiscal and inventory management.
office software
2w
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Process Engineer 2
Indianapolis, Indiana, United States
$67k-$101k/yr OnsiteFull Time
4+ YOEBachelor's degree in a life science or engineering discipline and 4+ years in pharmaceutical operations and US and European GMP requirements and FDA guidelines. Strong technical engineering and project skills required.
Microsoft Suite, Microsoft Visio, AutoCAD, JMP, Minitab, PLC
1w
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Project Manager, CQV
Indianapolis, Indiana, United States
OnsiteFull Time
7+ YOE7+ years validation/project management experience in life sciences or FDA-regulated environments, BS in engineering, strong cGMP/validation, risk assessment, technical writing, and leadership skills.
GAMP, 21 CFR Part 11, FMEA, HAZOP, Fault Tree Analysis
1mo
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CSV Engineer - Automation Engineering
Lebanon or Carmel or Indianapolis
$66k-$172k/yr OnsiteFull Time
2+ YOEB.S. in Engineering required, 2+ years in FDA-regulated environments, experience with computer system validation for automation systems, knowledge of GxP/GMP and data integrity, and authorized to work in the U.S.
DCS, SCADA, BMS, MES, Historian, Building Management System, Data Historian, Automated Storage and Retrieval System, QMS, Kneat, ALM, Valgenesis, DeltaV, Rockwell, Syncade, LabVantage, OSI PI, Site Historian, GAMP, 21 CFR Part 11
2w
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Process Engineer 2
Indianapolis, Indiana, United States
$67k-$101k/yr OnsiteFull Time
4+ YOEBachelor’s degree in a relevant science or engineering field, 4+ years in pharmaceutical operations and GMP/FDA requirements; preferred skills include Microsoft tools, AutoCAD, Visio, FMEA, Minitab, or JMP.
Microsoft Suite, Microsoft Visio, AutoCAD, Minitab, JMP, PLC
3w
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Product Development Engineer
Indianapolis, Indiana, United States
OnsiteFull Time
Bachelor-level engineering degree, product development experience, knowledge of FDA and ISO 13485/14971, DHF and risk management, CAD and Microsoft Office skills, strong communication and project management.
CAD, Microsoft Office Suite
3w
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Mixer - 3rd Shift- Bakery Plant
Indianapolis, Indiana, United States
$22-$23/hr OnsiteFull Time
0+ YOEMinimum 3 months production experience; experience in food processing, automated machinery (PLCs/MMIs), USDA/FDA/OSHA/GMP environments; SAP proficiency; ability to lift 50+ lbs.
PLC, MMI, SAP
6d
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Regulatory Coordinator | On-site, Indianapolis, IN
Indianapolis, Indiana, United States
$60k-$70k/yr OnsiteFull Time
3+ YOEBachelor's degree in quality, risk management, or a related field; English proficiency; US FDA and ISO regulatory experience; Microsoft Word, Adobe Acrobat, and Microsoft Excel proficiency; 3+ years preferred.
Microsoft Word, Adobe Acrobat, Microsoft Excel
1w
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Customs Brokerage Agent
Plainfield, Indiana, United States
OnsiteFull Time
2+ YOE2+ years customs brokerage experience processing entries and PGAs (including FDA), ability to prepare accurate entry declarations, billing, work under pressure, strong attention to detail and communication skills.
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