Director of Q&RA MBD North America

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:
Join our team as Quality Director and make a meaningful impact on health and safety. In this leadership role, you'll guide quality assurance strategy and develop a culture of excellence across our manufacturing sites. Working at the intersection of innovation and compliance, you'll lead quality initiatives that ensure our products meet the highest standards while enabling scientific discoveries. You'll oversee all QA activities, maintain regulatory compliance, and work collaboratively to improve business outcomes. This position offers the opportunity to build and implement quality systems that support our mission of enabling customers to make the world healthier, cleaner, and safer.

REQUIREMENTS:
• Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of strategic quality leadership experience in regulated medical device or pharmaceutical manufacturing
• Preferred Fields of Study: Engineering, Physical Sciences, Biology, Chemistry, or related scientific field
• ASQ Quality Manager Certification preferred
• ASQ Lead Auditor Certification preferred
• 5+ years proven experience as a site quality lead
• Demonstrated expertise in FDA CFR 820, ISO 13485/9001, MDR, and risk management (ISO 14971)
• Strong experience managing CAPA systems and quality improvement initiatives
• Proficiency in quality tools including FMEA, SPC, and risk management methodologies
• Experience with problem-solving techniques such as PPI, 8D, DMAIC, and PPS
• Experience leading and developing large quality teams (6-8 direct reports, 50+ indirect)
• Experience working with external regulatory authorities and managing inspections
• Ability to build cross-functional partnerships and collaborate at all organizational levels
• Proficiency in strategic planning and execution of quality initiatives
• Success in transitioning organizations from quality control to quality assurance
• Experience with Lean or Six Sigma improvement systems preferred
• Excellent communication and presentation skills
• Change management and organizational development capabilities
• Ability to travel 25-30% of time
• Electromechanical manufacturing experience preferred