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Principal Design Quality Engineer, Clinical

2 months ago

Wilmslow, Cheshire East, United Kingdom Waters Full time
Job Summary

We are seeking a highly skilled Principal Design Quality Engineer, Clinical to join our team at Waters Corporation. As a key member of our Clinical Design Quality team, you will be responsible for ensuring the development of all new IVD products complies with applicable regulatory standards and systems.

Key Responsibilities
  • Assume a Subject Matter Expert (SME) role on Product Development process activities and related workflows in relation to regulatory compliance, providing solution-based problem resolution.
  • 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, specifically deliverables related to product safety, usability, risk management, compliance, product performance, and registration.
Requirements
  • Minimum of a Bachelor's Degree required, preferably in Chemistry, Medical, or Science.
  • Extensive demonstrable experience of leading quality assurance activities supporting product development in a medical device environment, including ISO 13485, ISO 14971, ISO 62304, ISO 62366, and applicable good manufacturing practice regulations.
  • 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 the world's leading specialty measurement company, pioneering chromatography, mass spectrometry, and thermal analysis innovations serving the life, materials, and food sciences for over 60 years. We are committed to creating business advantages for laboratory-dependent organizations to enable significant advancement in healthcare delivery, environmental management, food safety, and water quality.

At Waters, 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. We're all in it together, delivering benefit as one to provide the insights needed today to solve the challenges of tomorrow.

Diversity and inclusion are fundamental to our core values at Waters Corporation. We 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.