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

PPD (Thermo Fisher) UK

Middletown, United States
On-site
Quality assurance processes
Fda 21 cfr part 820 compliance
Iso 13485 compliance
Thermo Fisher Scientific is seeking a Quality Engineering Supervisor for their Middletown, VA facility, focused on overseeing the quality assurance processes for medical devices and clinical diagnostic reagents. The role requires strong leadership, quality engineering experience, and a commitment to product safety and regulatory compliance

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: 85

Thermo Fisher Scientific is seeking a Quality Engineering Supervisor for their Middletown, VA facility, focused on overseeing the quality assurance processes for medical devices and clinical diagnostic reagents. The role requires strong leadership, quality engineering experience, and a commitment to product safety and regulatory compliance.

Skills & Requirements

Must-have

  • Quality assurance processes
  • FDA 21 CFR Part 820 compliance
  • ISO 13485 compliance
  • IVDR compliance
  • GMP requirements
  • CAPA and root cause analysis
  • Risk-based quality methodologies

Nice-to-have

  • Lean and Six Sigma methodologies
  • Data-driven improvement initiatives
  • Customer and regulatory audits

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)
  • Black Belt in Engineering Projects highly desired

Work Rights

Must be legally authorized to work in the United States without sponsorship

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