Thermo Fisher is looking to solve the problem of maintaining and improving quality and compliance at their Marietta, Ohio site, specifically in the production of temperature control products.
Requirements
- ISO 13485
- 21CFR820
- EU MDR
- Customer Requirements
- LEAN Enterprise approaches
- Statistical Process Control
- Root cause investigations, process validations, and compliance systems
Responsibilities
- Maintain a Quality Organization by anticipating and identifying customer needs and priorities and integrating them into the Quality System
- Ensure the site maintains continued compliance to ISO 13485, 21CFR820, EU MDR, Customer Requirements and others as necessary
- Develop goals and objectives that stretch boundaries by detailing specific continuous improvement activities focused on enhancing internal process and test yields
- Interact with Customers and Suppliers, when required, to promote external relationships or resolve opportunities.
- Promote LEAN Enterprise approaches with a quality principled focus that includes Daily Standard Work and continuous focus on processes.
- Create and maintain both a Quality-centric and Quality-focused culture for all production activities
- Perform all job duties in a safe manner and obey all safety policies and procedures
Other
- Bachelor Degree or equivalent experience required, with a preference for degrees in Engineering, Quality Management, Biomedical, or related fields
- 8+ years of experience in dynamic roles within manufacturing companies producing electro-mechanical products
- 3+ years in a leadership role
- Ability to travel (domestic and international) up to 10%
- Proven planning, organizational, and communication skills
