Quality Engineering Supervisor (Clinical Diagnostic Reagents)

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

Location/Division Specific Information

Join our Middletown, VA team within Thermo Fisher Scientific's Engineering division where we strictly adhere to outstanding quality standards and innovative practices. Relocation assistance is NOT provided. 

Discover Impactful Work:

Join a mission-driven organization dedicated to improving human health. As a Quality Engineering Supervisor, you will support the manufacturing of medical devices and clinical diagnostic reagents that empower customers to detect disease, accelerate research, and protect patient health. Your leadership will directly contribute to delivering safe, compliant, and high-quality products that make a real-world impact.

A day in the Life:

• 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.
• Partner with Operations, Technical Operations, Manufacturing Engineering, Regulatory, and Supply Chain to resolve quality issues and ensure robust product and process controls.
• Review and approve quality documentation, including nonconformances, CAPAs, deviations, and validation protocols, ensuring adherence to established standards.
• Support raw material qualification, lot release activities, and reagent manufacturing quality oversight.
• Analyze quality metrics to identify trends and lead data-driven improvement initiatives.
• Participate in internal, customer, and regulatory audits, ensuring readiness and alignment with quality system expectations.
• Drive continuous improvement through Lean, Six Sigma, and risk-based quality methodologies (FMEA, risk assessments).

Keys to Success:

Your success will be driven by your ability to lead and develop a skilled quality team, influence cross-functional partners, and apply strong problem-solving skills in a regulated environment. A passion for continuous improvement and unwavering commitment to product and patient safety are essential.

Education

• Bachelor’s degree in Engineering, Life Sciences, Chemistry, Biology, or a related technical field preferred.

Experience

• Proven experience in Quality Engineering within medical device, in vitro diagnostics (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.
• Familiarity with validation, statistical techniques, and design/process controls preferred.

Knowledge, Skills, Abilities

• Strong analytical and problem-solving abilities, including use of structured tools (5 Whys, Fishbone, DOE, etc.).
• Excellent communication and interpersonal skills with the ability to influence cross-functional teams.
• Deep understanding of regulated manufacturing environments and documentation requirements.
• Ability to troubleshoot complex quality and technical issues.
• Strong organization, prioritization, and time-management abilities.
• Commitment to product integrity and patient safety.

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

• Must be able to pass a comprehensive background check, which includes a drug screening.
   

Physical Requirements / Work Environment

Work in a dynamic and collaborative office and manufacturing environment. Ability to perform tasks that involve physical activity, such as standing for extended periods and lifting lightweight materials.