Design Quality Assurance 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

• BS degree in Engineering or in a Science field such as Chemistry, Microbiology, Biology, or Biochemistry.
• 7+ years of Quality Assurance experience (Quality Engineering, Quality Assurance, Quality Control, Supplier Quality).
• 5 + years of experience in New Product Introduction activities.
• 5 + years in the Medical Device, In-Vitro Diagnostics, or other regulated industry.

EXPERIENCE

• Demonstrated understanding of product development lifecycles, design change and change control, product validation methodologies, design transfer, and manufacturing/ production process control methodologies.
• Experience with applicable FDA, European and other relevant clinical/regulatory requirements, and international standards, including ISO 9001, ISO 13485, ISO 14971, EU IVDR/MDR, 21CFR 820 Quality System Regulation, etc.
• Mentoring and team management.

KNOWLEDGE, SKILLS, ABILITIES

• Strong verbal and written communication skills and can communicate at multiple levels in the organization.
• Ability to work efficiently within a team in a fast-paced changing environment.
• Strong leadership, including the ability to provide positive and constructive feedback to build positive relationships and improve business results.
• Experience working in a broader enterprise/cross division business unit model preferred.

Please refer the Job description for details