Thermo Fisher Scientific · 11 hours ago
Quality Engineering Supervisor
Middletown, VA
Full-time
Onsite
Mid, Senior LevelThermo Fisher Scientific is 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, ensuring the delivery of safe and high-quality products that make a real-world impact.
Research
Responsibilities
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)
Qualification
Required
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
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
Preferred
Bachelor's degree in Engineering, Life Sciences, Chemistry, Biology, or a related technical field
Familiarity with validation, statistical techniques, and design/process controls
Company
Thermo Fisher Scientific
The world leader in serving science To serve science, Thermo Fisher Scientific needs to stay ahead of it, we need to anticipate customer needs.
10001+ employees
H1B Sponsorship
Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (272)
2024 (224)
2023 (233)
2022 (342)
2021 (315)
2020 (227)
Funding
Current Stage
Late StageLeadership Team
Heather Stewart
HR Business Partner - Global Enterprise Services
Laura Green
Associate Human Resources Business Partner
Company data provided by crunchbase