JOB DESCRIPTION

Lead Quality at our Marietta, Ohio site as part of our outstanding Site Leadership Team!
The successful candidate will develop and deploy the quality and compliance strategic plan, applying Lean, Continuous Improvement, and Statistical Process Control to deliver flawless temperature control products. Establishing rapport with all colleagues is crucial to leading the compliance culture across the site. Mentoring emerging colleagues in root cause investigations, process validations, and compliance systems is also essential.

What will you do?

• 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
• Perform as a Role Model Leader, acting in compliance with the Thermo Fisher Code of Ethics and the 4-I Values (Integrity, Intensity, Involvement and Innovation).
• Perform other duties and cross training as assigned

EDUCATION:

• Bachelor Degree or equivalent experience required, with a preference for degrees in Engineering, Quality Management, Biomedical, or related fields

EXPERIENCE:

• 8+ years of experience in dynamic roles within manufacturing companies producing electro-mechanical products
• 3+ years in a leadership role
• Preference will be given to candidates with regulatory expertise in International Standards ISO-13485:2016, EU MDR, and 21 CFR Part 820 FDA Quality Systems Regulation.
• Proven planning, organizational, and communication skills
• Experience leading teams in the implementation of quality improvement systems

KNOWLEDGE, SKILLS, ABILITIES:

• Effective presentation skills to communicate Quality Plans and Quality Management Systems
• Ability to travel (domestic and international) up to 10%
• Physical Demands:
• Ability to sit at a computer workstation in an office environment
• Frequently walk, sit, talk, hear, smell, and see/distinguish color
• Climb stairs, stand, bend, stretch, reach, and kneel while exposed to noise, fumes, dust, and dirt in the manufacturing area
• Occasionally lift up to 40 pounds

• 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
• Perform as a Role Model Leader, acting in compliance with the Thermo Fisher Code of Ethics and the 4-I Values (Integrity, Intensity, Involvement and Innovation).
• Perform other duties and cross training as assigne