Design Quality Assurance Manager

1 week ago


Milwaukee, Wisconsin, United States Thermo Fisher Scientific Full time
Design Quality Assurance Manager

Thermo Fisher Scientific is seeking a highly skilled Design Quality Assurance Manager to lead all aspects of the design control and new product development lifecycle. This role will be responsible for providing guidance to project core teams on user and product requirements, functional specifications, design verification and validation, risk management, design reviews, design changes, and design transfer.

The ideal candidate will have a strong 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. is required.

This is a challenging and rewarding role that requires strong leadership, communication, and problem-solving skills. The successful candidate will be able to work efficiently within a team in a fast-paced changing environment and provide positive and constructive feedback to build positive relationships and improve business results.

Responsibilities:

  • Lead and support design control activities
  • Provide guidance to project core teams on user and product requirements
  • Develop and implement design verification and validation plans
  • Manage design changes and design transfer
  • Ensure compliance with applicable regulatory requirements and international standards

Requirements:

  • BS degree in Engineering or a Science field
  • 7+ years of Quality Assurance experience
  • 5+ years of experience in New Product Introduction activities
  • 5+ years in the Medical Device, In-Vitro Diagnostics, or other regulated industry

What We Offer:

  • Competitive remuneration and annual incentive plan bonus
  • Healthcare and a range of employee benefits
  • Opportunities for career growth and development

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.



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