When you’re part of the team at Thermo Fisher Scientific, 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.
This newly created role will based in Asheville, NC and will lead all QA activities for our Laboratory Equipment Technologies (LET) Business Unit. LET is made up of four businesses: Cold Storage; Centrifuges; Temperature Control; and Biological Safety Cabinets, CO2 Incubators and Orbital Shakers. LET is comprised of a large business unit which brings together a winning combination of innovation and customer focus with significant growth potential.
How will you make an impact?
Our Quality department is based on collaboration 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 Technologies (LET) Business Unit globally. This position will lead all QA activities at the various LET 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. This position will be the single point of contact to the business unit that will lead quality improvements, report of progress and liaise cross functionally to improve the overall quality and compliance of LET products.
What will you do?
- Build and drive a QA strategy and vision for the LET Business Unit that supports growth and compliance readiness.
- Provide transformational leadership to the quality function to promote a strong quality culture necessary to ensure customer and business expectations are continuously met and exceeded.
- Leads the operations quality function for LET sites to effectively deliver business objectives (5 direct reports; 70 indirect). Primary sites in North America and Germany
- Drive continuous improvement activities and projects to move the organization from QC to QA.
- Steer and develops the quality system to fulfill international quality system requirements (e.g. FDA CFR 820, ISO 13485/9001, IVDD) to enable business growth.
- Develop clear visibility to new regulations; translate those regulations into operational requirements for site quality leaders to implement within sufficient lead-times.
- Assure quality system requirements are compliant, efficient and effective to meet requirements of regulated and non-regulated sites/products.
- Improves and manages Corrective and Preventive Action System. Works with various departments to identify actions required to assure corrective and preventative actions are properly documented and follows up to initiate and monitor timely completion of actions.
- Creates 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 to enable business growth.
How will you get there?
- B.S. Degree in Engineering or scientific discipline.
- A minimum of 10 years of strategic Quality leadership experience in a regulated medical-device manufacturing company.
- A minimum of 5 years’ experience managing 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).
- Must have experience working with and managing multiple projects and teams simultaneously across a matrixed organization.
- Electromechanical equipment manufacturing experience.
- Experience with Lean or Six Sigma improvement systems is preferred.
- 25%-30% travel requirement.
Knowledge, Skills, Abilities
- A decisive leader who’s able to inspire and motivate teams and can clearly communicate goals and objectives.
- Effectively communicates and presents to all levels internally and externally.
- ASQ Quality Manager Certified; ASQ lead auditor training is preferred.
- Training on CFRs/ISO 13485/9001 and risk management (ISO 14971) is preferred.
This position has been approved for relocation assistance.