Sr Product Quality Manager

at  Thermo Fisher Scientific

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.

EDUCATION:

• Minimum required education: Bachelor’s degree in engineering or related scientific discipline
• MBA or advanced engineering or scientific degree is preferred.

EXPERIENCE:

• Minimum 10 years’ experience in Quality Assurance management and leadership, preferably in Medical Device environment.
• Minimum 3 years in a Quality Leadership Role in a medical device company or other highly regulated industry such as aerospace or automotive. Experience in a startup environment is a plus.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Strong project leadership capability and ability to drive culture change. Working knowledge of ISO requirements. Experience working in a six sigma or TQM manufacturing environment.
• Proven experience in using data and statistical techniques to drive continuous improvements.
• Extensive knowledge and experience in validation process design and process validation, change control, and auditing quality management systems.
• Experience working with a broad range of people from manufacturing personnel to senior management.
• Experience in product development software and hardware quality systems and audits.
  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 global 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.
  Apply today! http://jobs.thermofisher.com
  Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

• Fosters a quality culture to achieve site-wide program success through measurable activity, metrics, and strong ability to influence teams in the areas of focus.
• Lead and inspire a strong product quality, supplier quality and receiving inspection team by hiring and developing strong product quality personnel, establishing, and actively managing performance expectations, and providing development and training opportunities.
• Coach and motivate product quality, supplier quality and receiving inspection team with a mix of (ISO 9001), CE-IVD (13485), and GMP (21CFR820) products.
• Manages multiple areas responsible for product quality and supplier quality.
• Drives consistent adoption of Quality Tools across the site, including 8D Corrective Action, Error Proofing, Failure Modes and Effects Analysis (FMEA), Design for Manufacturability (DFM), FAIRS/PPAP, Statistical Process Control (SPC), Design Validation and Process Validation testing (DVT/PVT), and Critical to Quality (CTQ) documentation.
• Impacts product quality for assigned products, working with Operations, Quality, R&D and Product Support teams affecting warranty costs, instrument installations, and customer allegiance.
• Determines priorities for projects regarding maintenance and improvement of site-specific systems; recommends priorities and actions for those controlled by outside resources (such as division or corporate IT systems) affecting the local product quality.
• Has the necessary independence and authority within the area, and through reporting relationships to initiate actions as needed to ensure the quality, safety and efficacy of all products.
• Other miscellaneous duties as assigned.