Principal Design Quality Engineer, Clinical

at  Waters Corporation

Overview:
Waters, the world’s leading specialty measurement company that cares about inclusion and diversity is seeking for a Principal Design Quality Engineer, Clinical to be located in Wilmslow,Manchester or Wexford, Ireland. This position will have a hybrid work schedule (two to three days per week on-site).
Clinical Design Quality supports development of all new IVD products in compliance to applicable regulatory standards / systems including ISO 13485, ISO 9001, IVDR 2017/746 & 21CFR 820.
The role provides support and enables the delivery of the product roadmap by evaluation and monitoring of product design and development activities, including Risk Management, for Waters Clinical Business Unit [IVD devices, RUO products and non-IVD products] to ensure conformity to Waters and regulatory requirements, plus input into continual improvement of processes and working practices.
Also supports post market activities (e.g. product release, design changes, non-conformances, CAPA, complaints, post-market surveillance), regulatory documentation creation and maintenance, supplier management, auditing and general Quality Management System (QMS) activities.

Responsibilities:

• Assume a Subject Matter Expert (SME) role on Product Development process activities and related workflows in relation to regulatory compliance, provide ‘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 including as appropriate: ISO 9001; ISO 13485; 21 CFR parts 11 and 820, ISO 62304, ISO 62366, ISO 14971.
• Mentor to 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.
• Actively participate in and/or facilitate the development, review and approval of requirements and deliverables required to support product development (planning, requirements, architecture, verification/validation etc.) including risk management, maintenance, configuration management and problem resolution.

Qualifications:

Education

• Minimum of a Bachelors Degree required. Chemistry, Medical or Science Graduate education is preferable

Experience

• 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.
• Desired – generation of product development collateral for regulatory submissions, IVDR technical files, 510K

Competencies

• Strong leadership, coaching and mentoring skills.
• Strong ability to lead staff dispersed across many different locations and cultures
• Strong organization/prioritization skills
• Exceptional interpersonal skills using written and oral communication are required, for example to ensure succinct report generation, effective communication with stakeholders, peer groups etc. across organization.
• Strong analytical skills with the ability to identify, diagnose, and solve problems with minimal direction and make decisions with confidence

Company Description:
Waters Corporation (NYSE: WAT), the world’s leading specialty measurement company, has pioneered chromatography, mass spectrometry and thermal analysis innovations serving the life, materials, and food sciences for more than 60 years. With more than 7,000 employees worldwide, Waters operates directly in 35 countries, including 15 manufacturing facilities, with products available in more than 100 countries. 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.
Working at Waters enables our employees to unlock the potential of their careers. Our global team is driven by purpose. 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 in order to solve the challenges of tomorrow.
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.

• Assume a Subject Matter Expert (SME) role on Product Development process activities and related workflows in relation to regulatory compliance, provide ‘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 including as appropriate: ISO 9001; ISO 13485; 21 CFR parts 11 and 820, ISO 62304, ISO 62366, ISO 14971.
• Mentor to 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.
• Actively participate in and/or facilitate the development, review and approval of requirements and deliverables required to support product development (planning, requirements, architecture, verification/validation etc.) including risk management, maintenance, configuration management and problem resolution