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

Thermo Fisher Scientific UK

Middletown, United States
**
Supervise quality engineers
Ensure fda 21 cfr part 820 compliance
Oversee iso 13485 compliance
** Thermo Fisher Scientific is seeking a Quality Engineering Supervisor to lead a team in the production of medical devices and clinical diagnostic reagents in Middletown, VA. The ideal candidate will possess significant experience in quality engineering within regulated environments, focusing on compliance and continuous improvement. **

Job Summary

  • Lead, mentor, and supervise a team of Quality Engineers supporting medical device and reagent production activities.
  • Oversee quality assurance processes to ensure compliance with FDA 21 CFR Part 820, ISO 13485, IVDR, and GMP requirements.
  • Drive continuous improvement through Lean, Six Sigma, and risk-based quality methodologies (FMEA, risk assessments).

Matching Summary

Match Score: 75

** Thermo Fisher Scientific is seeking a Quality Engineering Supervisor to lead a team in the production of medical devices and clinical diagnostic reagents in Middletown, VA. The ideal candidate will possess significant experience in quality engineering within regulated environments, focusing on compliance and continuous improvement. **

Skills & Requirements

Must-have

  • Supervise quality engineers
  • Ensure FDA 21 CFR Part 820 compliance
  • Oversee ISO 13485 compliance
  • Manage IVDR compliance
  • Adhere to GMP requirements
  • Resolve quality issues cross-functionally
  • Review quality documentation
  • Support lot release activities
  • Analyze quality metrics
  • Participate in audits

Nice-to-have

  • Continuous improvement mindset
  • Passion for product safety
  • Influence cross-functional partners
  • Problem-solving in regulated environment

Key Requirements

  • Bachelor's degree in Engineering, Life Sciences, Chemistry, Biology, or related technical field preferred
  • Proven experience in Quality Engineering within medical device, IVD, or clinical reagent manufacturing
  • Demonstrated success in team supervision or technical leadership roles
  • Experience with quality system regulations and standards (FDA QSR, ISO 13485, ISO 14971, GMP)
  • Hands-on experience with CAPA, root cause analysis, nonconformance investigation, and process improvements
  • Black Belt in Engineering Projects highly desired
  • Legally authorized to work in the United States without sponsorship

Work Rights

Must be legally authorized to work in the United States

Tailored Resume

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