Principal Design Quality Engineer Clinical

4 weeks ago

Wilmslow, Cheshire East, United Kingdom Waters Corporation Full time
Job Title: Principal Design Quality Engineer, Clinical

Waters Corporation, a leading specialty measurement company, is seeking a Principal Design Quality Engineer, Clinical to join our team. This role will be based in Wilmslow, Manchester or Wexford, Ireland, with a hybrid work schedule.

Job Summary:

The Principal Design Quality Engineer, Clinical will be responsible for supporting the development of new IVD products in compliance with regulatory standards, including ISO 13485, ISO 9001, IVDR 2017/746 & 21CFR 820. This role will provide leadership and direction on all quality activities necessary for design quality to achieve design control deliverables.

Key Responsibilities:
  • Assume a Subject Matter Expert (SME) role on Product Development process activities and related workflows in relation to regulatory compliance.
  • Act as Quality specialist in relation to design and development ensuring conformance and up-to-date information on applicable regulatory requirements.
  • Mentor Design Quality Engineers, Clinical on design control requirements and approach.
  • Provide interpretation guidance and mentorship on industry best practice deploying new, or changes to existing, processes and systems to improve the overall effectiveness, efficiency and compliance of the quality management system.
  • Evaluate the acceptability of products for release, ensuring customer requirements /specifications and internal Waters policies and procedures are met.
  • Provide leadership and direction on all quality activities necessary for the design quality to achieve design control deliverables.
Requirements:
  • Minimum of a Bachelors Degree required. Chemistry, Medical or Science Graduate education is preferable.
  • Extensive demonstrable experience of leading quality assurance activities supporting product development in a medical device environment - ISO 13485, ISO 14971, ISO 62304, ISO 62366 and applicable good manufacturing practice regulations including, 21 CFR part 820.
  • Extensive demonstrable experience in the application of design controls and risk management including design transfer, process validation and process control plans.
About Waters Corporation:

Waters Corporation is a global leader in specialty measurement solutions for laboratory-dependent organizations. Our team focuses on creating business advantages for laboratory-dependent organizations to enable significant advancement in healthcare delivery, environmental management, food safety, and water quality. We strive to be better, learn and improve every day in everything we do. We're the problem solvers and innovators that aren't afraid to take risks to transform the world of human health and well-being.

Diversity and inclusion are fundamental to our core values at Waters Corporation. It is our responsibility to actively implement programs and practices to drive inclusive behavior and increase diversity across the organization. We are united by diversity and thrive on it for the benefit of our employees, our products, our customers and our community. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or protected Veteran status.

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