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

PPD (Thermo Fisher) UK

Middletown, VA, USA
Fda 21 cfr part 820 compliance
Iso 13485 and ivdr standards
Team supervision of quality engineers
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 assurance processes to ensure strict regulatory compliance.
  • Drive continuous improvement initiatives using Lean, Six Sigma, and data-driven methodologies to enhance product safety and quality.

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 of Quality Engineers
  • CAPA and root cause analysis
  • GMP requirements in manufacturing

Nice-to-have

  • Lean Six Sigma Black Belt certification
  • FMEA and risk-based quality methodologies
  • Strong analytical problem-solving skills
  • Cross-functional influence capabilities
  • 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
  • Must be legally authorized to work in the US without sponsorship

Work Rights

Must be legally authorized to work in the United States

Tailored Resume

Cover Letter