Design Quality Assurance Engineer

Overview

Waters, the world's leading specialty measurement company that cares about inclusion and diversity is seeking for a Design Quality Engineer, Clinical, to be located in Milford, Massachusetts, USA. This position will have a hybrid work schedule ( 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

• 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 interpretation guidance 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

• Demonstrable experience of quality assurance activities - ISO 13485, ISO 14971, IEC 62304, IEC 62366 and applicable good manufacturing practice regulations including, 21 CFR part 820.
• Desired - demonstrable experience 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

Competencies

• Demonstrated practical approach towards problem solving
• Be able to work independently and as a member of a cross-functional team, to multi-task and prioritise to meet high expectations and tight deadlines.
• Strong organization/prioritization skills
• Strong 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.
• Computer literate, preferably with knowledge of software packages such as Microsoft 365, Atlassian, SAP.

 

 

Company Description

Waters Corporation (NYSE:WAT) 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 pioneering science. 

 

 

Diversity and inclusion are fundamental to our core values at Waters Corporation. It benefits our employees, our products, our customers and our community. Waters complies with all applicable federal, state, and local laws. Qualified applicants are considered without regard to sex, race, color, ancestry, national origin, citizenship status, religion, age, marital status (including civil unions), military service, veteran status, pregnancy (including childbirth and related medical conditions), genetic information, sexual orientation, gender identity, legally recognized disability, domestic violence victim status, or any other characteristic protected by law. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. All hiring decisions are based solely on qualifications, merit, and business needs at the time.

Key Words

Quality, Design, Assurance, Design control, 13485, 14971, IVD, device, clinical #LI-HH1