Laboratory Supervisor

Fresenius Medical Care

Irving, Texas, United States
Not specified
Bachelor's degree in engineering or related field
2 years quality engineer experience in manufacturing
Iso 13485 and 21 cfr part 820 compliance knowledge
Fresenius Medical Care is seeking a Laboratory Supervisor in Irving, Texas, responsible for overseeing the daily operations of the laboratory, managing quality control programs, and ensuring compliance with regulatory standards. The ideal candidate should have a background in Industrial, Chemical, or Biomedical Engineering, along with experience in quality engineering in a manufacturing environment

Job Summary

  • The Laboratory Supervisor will manage day-to-day technical, scientific, and administrative operations of the laboratory department.
  • This role requires establishing a robust Quality Control Program ensuring compliance with regulatory standards from specimen receipt to result reporting.
  • The successful candidate must supervise QC teams, maintain inspection-ready status for audits, and drive process improvements using data analysis.

Matching Summary

Match Score: 85

Fresenius Medical Care is seeking a Laboratory Supervisor in Irving, Texas, responsible for overseeing the daily operations of the laboratory, managing quality control programs, and ensuring compliance with regulatory standards. The ideal candidate should have a background in Industrial, Chemical, or Biomedical Engineering, along with experience in quality engineering in a manufacturing environment.

Skills & Requirements

Must-have

  • Bachelor's degree in Engineering or related field
  • 2 years Quality Engineer experience in manufacturing
  • ISO 13485 and 21 CFR Part 820 compliance knowledge
  • Experience with FDA and COFEPRIS audits
  • Proficiency in Trackwise, Windchill, and MINITAB tools
  • CAPA and NC management in medical device environment
  • SAP material management and BOM creation skills

Nice-to-have

  • Supplier quality nonconformance management
  • CMO complaint management and Quality Agreements
  • Process improvement project leadership
  • Cross-functional team collaboration skills
  • Technical protocol development expertise

Key Requirements

  • Bachelor's degree in Industrial, Chemical, or Biomedical Engineering
  • 2 years experience as a Quality Engineer in manufacturing
  • Knowledge of ISO 13485, 21 CFR Part 820.100, and audit participation
  • Experience managing CAPAs, NCs, and Master Production Records
  • Familiarity with SAP, Trackwise, Windchill, and MINITAB platforms

Work Rights

Not specified

Tailored Resume

Cover Letter