When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an exceptional strategy for the near term and beyond. Take your place on our strong team, and help us make significant contributions to the world.
- Ensure that Quality Management systems are adequately maintained and continuous improvements are implemented.
- Co-ordinate with various functions to ensure awareness and understanding of the Quality Management System. Plan and co-ordinate gap analysis exercises and provide advice on bridging the gap.
- Manage and oversee quality audits by plan and ensure quality audits findings and recommendations are rectified and implemented. Apprise management of quality audit findings and corrective actions taken.
- Ensure that the procedures and processes prescribed by the Quality management system are in place and implemented per requirement.
- Review the quality management system periodically to assess continued suitability and areas of possible improvement.
- Arrange for ISO9001, ISO13485, ISO14971 and FDA 21 CFR part 820 awareness training and further refresher training as needed.
- Co-ordinate and plan work of external audit such as Customer, ISO certification and Regulatory bodies.
- Ensure that systems and procedures are in compliance with ISO9001, ISO14001, ISO13485, ISO14971, FDA 21CFR Part 820, OHSAS 18001 and WHO Good Distribution Practices requirements.
- Mentor / supervise as assigned and ensure timely and accurate completion of quality projects through PPI initiatives.
- Support company goals, objectives and policy in compliance with QMS.
- Maintain electronic database of work flows and procedures.
- Support Plant wide activities and special projects, as assigned.
- Degree in Engineering (Mechanical or Electronics) or Degree in Sciences
- Work in a Quality Assurance function with managerial experience (Applicable to manager).
- Relevant working experience in ISO13485 and GMP environment preferred
- Ability to contribute in a global matrix organization effectively.
- Demonstrate leadership and implement change management.
- Able to think strategically and creatively.
- High standard of quality requirement.
- Ability to lead, mentor and facilitate problem solving and quality improvement process.
- Quality systems knowledge ISO9001, ISO13485, ISO14971 and 21CFR Part 820 requirements
At Thermo Fisher Scientific, each one of our 50,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. 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.