Director, Quality Assurance - LED

Work Schedule

Environmental Conditions

Job Description

When you’re part of the team, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

How will you make an impact?

Our Quality department is based on teamwork and partnership, with all of us working together to support and promote quality across the company. We are looking for a forward thinking quality leader for the Laboratory Equipment Division (LED) Business Unit globally. Ideally located in Asheville, NC; the Director will lead all QA activities at the various LED manufacturing sites to assure high quality products are delivered to customers, maintain a strong state of regulatory compliance and work cross-functionally to improve business outcomes.

What will you do?

• Build and drive a QA strategy and vision for the LED Business Unit that supports growth and compliance readiness.
• Provide ground-breaking leadership to the quality function to promote a strong quality culture vital to ensure customer and business expectations are continuously met and exceeded.
• Lead and encourage the operations quality function for LED sites to effectively deliver business objectives (8-10 direct reports; 130 indirect). Primary sites in North America and Europe.
• Drive continuous improvement activities and projects to move the organization from QC to QA.
• Steer and develops the system to fulfill international quality system requirements (e.g. FDA CFR 820, ISO 13485/9001, MDR) to enable business growth.
• Develop clear access to new regulations; translate those regulations into operational requirements for site quality leaders to implement within sufficient lead-times.
• Assure quality requirements are compliant, efficient and effective to meet requirements of regulated and non-regulated sites/products.
• Improve and lead Corrective and Preventive Action System. Works with various departments to identify actions required to assure corrective and preventative actions are accurately detailed and follows up to initiate and supervise timely completion of actions.
• Build cross functional alliances with local and corporate teams to ensure participation in and understanding of associated initiatives.
• Collaborate with Human Resources to assure training is available to all employees regarding the Quality System and the Quality Policy.
• Manage key quality business metrics that align with customer expectations to assure year-over-year improvement.

How will you get here?

Education

• B.S. Degree in Engineering or scientific subject area.

Experience

• 10 years of strategic Quality leadership experience in a regulated medical-device manufacturing company.
• 5 years’ proven experience leading the quality organization for multiple sites.
• Experience dealing with external regulators.
• Hands-on experience in managing CAPA system.
• Experience with FMEA (Failure Mode and Effects Analysis), SPC (Statistical Process Controls) and other risk management tools.
• Successful experience with problem-solving techniques such as PPI (Practical Process Improvement), 8D (8 Disciplines Model), DMAIC (Define Measure Analyze Control), PPS (Practical Problem Solving).
• Electromechanical manufacturing experience is preferred.
• Experience with Lean or Six Sigma improvement systems is preferred.
• 25%-30% travel requirement.

Knowledge, Skills, Abilities

• A decisive leader who’s able to encourage and empower teams and can clearly communicate goals and objectives.
• ASQ Quality Manager Certified; ASQ lead auditor training is preferred.
• Training on CFRs/ISO 13485/9001 and risk management (ISO 14971) is preferred.

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

We offer competitive salary, an annual incentive bonus plan, a 401K with company match up to 6%, tuition reimbursement, and a range of other employee benefits!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.