Quality Engineering Supervisor
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Job Location:
Middletown, DE - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Work Schedule
First Shift (Days)Environmental Conditions
OfficeJob Description
At Thermo Fisher Scientific team youll 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 Scientifics Engineering division where we strictly adhere to outstanding quality standards and innovative practices.
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
- Bachelors 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.
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.
Required Experience:
Manager
Key Skills
- Hospital Experience
- Hotel Experience
- Taleo
- Calibration
- Pool Maintenance
- Maintenance Management
- Maintenance
- Quality Control
- Boiler
- Oil & Gas Experience
- Programmable Logic Controllers
- Supervising Experience
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
