39 fda jobs at 13 companies in Elkhart, IN
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Quality Supervisor
Kendallville, Indiana, United States
$69k-$86k/yr OnsiteFull Time
Requires food or manufacturing quality knowledge, leadership, communication, statistical process knowledge, and the ability to manage multiple assignments. Food, FDA, and USDA experience preferred.
KHMS, FSSC, ISO, USDA, FDA, HACCP, Agile, GEMBA
3d
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Quality Engineer, Service
Kalamazoo, Michigan, United States
$70k-$111k/yr OnsiteFull Time
0+ YOEBachelor’s degree in engineering or a related technical discipline and 0+ years of engineering experience. Medical device, regulated industry, quality systems, risk analysis, and FDA or ISO knowledge preferred.
FDA, ISO
3d
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1st Shift Quality Control Inspector
Warsaw, Indiana, United States
OnsiteFull Time
2+ YOEHigh school diploma required; associate degree preferred. Requires 2+ years in manufacturing quality control or inspection, measurement tools, technical drawings, ISO and FDA regulations, and quality management systems.
ISO, FDA, calipers, micrometers, gauges
4d
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Buyer/Planner
Kalamazoo, Michigan, United States
HybridFull Time
Requires a business or supply chain bachelor's degree or equivalent experience, Microsoft Office and Excel knowledge, MRP experience, and FDA-regulated or ISO environment experience.
Microsoft Office Suite, Microsoft Excel, IQMS, MRP
1w
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Production Supervisor, Packaging (2nd shift) - Sturgis, MI Plant
Sturgis, Michigan, United States
$61k-$123k/yr OnsiteFull Time
4+ MgmtLead packaging production teams, ensure FDA/OSHA compliance, manage up to 30 direct reports, drive operational efficiency, and oversee labor and quality metrics.
3w
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Plasma Center Paramedic – EMT-P
Elkhart, Indiana, United States
$24-$33/hr OnsiteFull Time
2+ YOEState EMT-Paramedic license, CPR and AED certification, basic IV therapy, FDA-approved Medical Support Specialist training, and 2 years clinical experience.
1w
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Production Supervisor, Packaging (2nd shift) - Sturgis, MI Plant
Sturgis, Michigan, United States
$61k-$123k/yr OnsiteFull Time
4+ YOEBachelor's in related field or HS/GED plus 4+ years manufacturing leadership; experience with regulatory compliance (FDA, OSHA), people leadership, operational execution, and communication skills.
2w
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Senior Mechanical Engineer
Toledo or Midland or Columbus or Lima or St. Paul or Portage or Austin or Huntsville
$150k-$160k/yr OnsiteFull Time
10+ YOEBachelor's in Mechanical Engineering, PE preferred or in-progress,10+ years engineering experience in pharmaceutical/life sciences facilities, experience with FDA/cGMP environments, project leadership and multidisciplinary collaboration.
Microsoft Office, AutoCAD
1mo
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Quality Engineer I
Warsaw, Indiana, United States
OnsiteFull Time
4+ YOEBachelor's in engineering or 4+ years medical device experience plus ASQ CQE/CMQ-QE; knowledge of FDA/ISO/GMP, FMEA, PPAP, CAPA, statistical methods, and audit participation.
Microsoft Word, Microsoft Excel, Microsoft Outlook, Microsoft PowerPoint, Minitab
1mo
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Regulatory Affairs Manager (11155)
Warsaw, Indiana, United States
$113k-$142k/yr RemoteFull Time
6+ YOEBachelor's in life sciences/engineering required; 6+ years regulatory affairs experience (including FDA/EU submissions); regulatory strategy, team leadership, and regulatory IT/system experience; Power BI and PowerPoint proficiency.
Power BI, Microsoft PowerPoint
2w
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Supervisor Donor Services (Phlebotomy)
Portage, Michigan, United States
FieldFull Time
1+ YOE1+ MgmtSupervisory experience (1+ years), customer service and phlebotomy/healthcare experience preferred, valid driver’s license, ability to travel including overnight, MS Office and Hemasphere familiarity, knowledge of regulatory requirements (FDA, CLIA, AABB).
Microsoft Word, Microsoft Excel, Microsoft Outlook, Microsoft PowerPoint, Hemasphere, Title 21
1mo
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Quality Associate II - QMS
South Bend, Indiana, United States
OnsiteFull Time
3+ YOEBachelor's in a science field, 3+ years quality experience with medical device/IVD, knowledge of ISO 13485/9001/14971 and FDA QMSR (21 CFR 820), CAPA and audit experience, strong analytical and Microsoft Office skills.
Microsoft Word, Microsoft Excel, Microsoft Outlook
2mo
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Mammography Tech PRN
La Porte, Indiana, United States
OnsitePart Time
1+ YOEState-licensed radiologic technologist with 1+ years radiologic imaging experience; ARRT radiography required, ARDMS or ARRT mammography required/obtainable within 6 months; BCLS required; PACS/EMR proficiency; knowledge of FDA/MQSA and ACR standards.
PACS, Electronic Medical Records (EMR)
2mo
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THCE Biomedical Equipment Technician II
Plymouth or Mishawaka
OnsiteFull Time
3+ YOEAssociates in medical electronics or related field required; 3+ years maintaining, calibrating, and repairing medical devices; CBET preferred; knowledge of anatomy/medical terminology, OSHA/NFPA/FDA/JCAHO standards, basic PC skills, and ability to lift up to 100 lbs.
1w
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Quality Supervisor
Kendallville, Indiana, United States
$69k-$86k/yr OnsiteFull Time
Requires food, manufacturing quality, operations, science, or engineering knowledge; quality systems expertise; leadership, communication, statistical process, planning, and prioritization skills. Must respond to off-shift and weekend emergencies.
KHMS, FSSC, ISO, USDA, FDA, HACCP, Agile
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