Design Quality Assurance Engineer

Waters Corporation is a global leader in analytical instruments, separations technologies, and software, serving the life, materials, food, and environmental sciences for over 65 years. Our Company helps ensure the efficacy of medicines, the safety of food and the purity of water, and the quality and sustainability of products used every day. In over 100 countries, our 7,600+ passionate employees collaborate with customers in laboratories, manufacturing sites, and hospitals to accelerate the benefits of groundbreaking science. 

Design Quality Assurance Engineer

Overview

Waters, the world's leading speciality measurement company that cares about inclusion and diversity, is recruiting for a Design Quality Assurance Engineer to be positioned in Wilmslow, Cheshire, UK. This position will have a hybrid work schedule (three days per week on-site).

Clinical Design Quality supports the development of all new IVD products in compliance with 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

• 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, IEC 62304, IEC 62366, ISO 14971.
• Collaborate with Design Quality Engineers, Clinical on design control requirements and approach
• Provide mentorship on industry methods for implementing process changes to improve quality system compliance.
• Evaluate the acceptability of products for release, ensuring customer requirements /specifications and internal Waters policies and procedures are met.
• Offer mentorship and direction on all quality tasks crucial for improving quality standards to ensure consistency in advancing work, especially work related to product safety, usability, risk management, alignment, product performance, and registration.
• Participate in developing, reviewing, and approving requirements for product development, risk management, maintenance, and problem resolution.

Qualifications

Education:

• A Bachelor's Degree or equivalent experience required, in Chemistry, Medical, or Science, is preferred. 

Experience:

• Proven experience in quality assurance activities - ISO 13485, ISO 14971, IEC 62304, IEC 62366 and applicable good manufacturing practice regulations, including 21 CFR part 820.
• Demonstrated expertise in the application of design controls and risk management, including design transfer, process validation and process control plans.
• Desired – product development in a medical device environment

Proficiencies:

• A practical approach towards problem-solving
• Be capable of working independently and as part of a multi-functional team, balancing multiple tasks and prioritizing to meet high demands and tight deadlines.
• Strong organization/prioritization skills
• Strong interpersonal skills in verbal and written communication required for clear report writing and effective interaction with colleagues and peers.
• Computer literate, preferably with knowledge of software packages such as Microsoft 365, Atlassian, and SAP.

In addition to salary, we work flexibly and provide 25 days' holidays, excellent family-friendly benefits such as attractive employer pension contribution, life assurance, income protection and private medical. With Waters, there are plenty of opportunities for you to grow, develop and contribute.