Manager Quality Engineer

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

DESCRIPTION:

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.

Location: Middletown VA.

Relocation assistance is NOT provided.

• Lead develop and manage a team of Quality Engineers fostering a high-performance culture focused on accountability growth and continuous improvement.
• Own and drive the site quality engineering strategy aligned with business objectives regulatory requirements and global quality standards.
• Ensure compliance with FDA 21 CFR Part 820 ISO 13485 IVDR GMP and other applicable regulations across all quality engineering activities.
• Serve as a key quality leader partnering with Operations Technical Operations Manufacturing Engineering Regulatory Affairs and Supply Chain to ensure robust product and process controls.
• Provide oversight and final approval for critical quality system elements including CAPAs nonconformances deviations change controls and validation activities.
• Lead complex investigations and ensure effective root cause analysis risk assessment and sustainable corrective/preventive actions.
• Oversee raw material qualification supplier quality integration and lot release processes to ensure product integrity.
• Establish and monitor quality KPIs using data analytics to drive proactive improvements and operational excellence.
• Lead regulatory customer and internal audits ensuring site readiness and successful outcomes.
• Champion continuous improvement initiatives using Lean Six Sigma and risk-based methodologies (FMEA risk management).
• Drive talent development succession planning and organizational capability within the quality engineering function.

REQUIREMENTS
Education

• Bachelors degree in engineering Life Sciences Chemistry Biology or a related technical field required. Advanced degree (MBA MS) preferred.

Experience

• 3 years of experience in Quality Engineering within medical devices in vitro diagnostics (IVD) or clinical reagent manufacturing.
• Proven leadership experience managing teams and driving organizational performance.
• Strong expertise in quality systems and regulations (FDA QSR ISO 13485 ISO 14971 GMP IVDR).
• Demonstrated success leading complex quality initiatives investigations and cross-functional projects.
• Experience with validation statistical methods and design/process controls.
• Lean Six Sigma certification or equivalent experience preferred.

Knowledge Skills Abilities

• Strong leadership and people development skills with the ability to influence and inspire teams.
• Strategic thinker with strong business acumen and decision-making capability.
• Advanced problem-solving skills using structured methodologies (5 Whys Fishbone DOE etc.).
• Excellent communication and stakeholder management skills across all organizational levels.
• Deep understanding of regulated manufacturing environments and quality systems.
• Ability to manage multiple priorities in a fast-paced environment.
• Strong commitment to quality compliance and patient safety.
• Must be legally authorized to work in the United Stateswithoutsponsorship.
• Must be able to pass a comprehensive background check whichincludes a drug screening.