Quality Engineering Supervisor (clinical Diagnostic Reagents) - Middletown, Va

Thermo Fisher Scientific UK

Middletown, VA, US
Fda 21 cfr part 820 compliance
Iso 13485 and ivdr standards
Team supervision and mentorship
Join a mission-driven organization dedicated to improving human health through the manufacturing of medical devices and clinical diagnostic reagents

Job Summary

  • Join a mission-driven organization dedicated to improving human health through the manufacturing of medical devices and clinical diagnostic reagents.
  • Lead, mentor, and supervise a team of Quality Engineers while overseeing quality assurance processes to ensure strict regulatory compliance.
  • Drive continuous improvement initiatives using Lean, Six Sigma, and risk-based quality methodologies to deliver safe products.

Matching Summary

Join a mission-driven organization dedicated to improving human health through the manufacturing of medical devices and clinical diagnostic reagents.

Skills & Requirements

Must-have

  • FDA 21 CFR Part 820 compliance
  • ISO 13485 and IVDR standards
  • Team supervision and mentorship
  • CAPA and root cause analysis
  • GMP manufacturing environment

Nice-to-have

  • Lean Six Sigma Black Belt
  • FMEA and risk assessment skills
  • Statistical techniques experience
  • Cross-functional influence ability
  • Passion for continuous improvement

Key Requirements

  • Bachelor's degree in Engineering or Life Sciences
  • Proven experience in Quality Engineering for medical devices
  • Demonstrated success in team supervision roles
  • Legal authorization to work in the United States without sponsorship

Work Rights

Must be legally authorized to work in the US without sponsorship

Tailored Resume

Cover Letter