Waters Design Quality Engineer in United States
This position will be accountable for concurrent quality engineering activities associated with new product development, on-market product design change, risk management, conformity to applicable quality management systems and Waters requirements for instrument hardware and software. Primary responsibility will be to provide quality engineering support in the following areas: design controls, previous product analysis, change control, post market review, quality planning, continuous improvement, establishment of appropriate requirements management and traceability.
Participate in new product development projects by providing technical quality engineering support for assigned projects. Ensure engineering and scientific analyses are employed and design history files comply with company policies and applicable standards and regulations. Transfer knowledge of inherent product design risks and mitigating controls resulting from the design process to colleagues.
Key deliverables include, but are not limited to performing previous product analysis on similar products and risk management activities. Supporting project team activities for requirements management, design reviews, design verification, design validation, design transfer to manufacturing, documentation completion tracking, and product release authorization for distribution of product.
Collaborate with Risk Management activities according to company policy, procedures and ISO 14971, including Risk Management Planning, Preliminary Hazard Analysis, FMEA, Software Risk Analysis, Risk Management Report and Risk Management File.
Collaborate with the organisations responsible for execution of LC/MS hardware and instrument control software development to ensure that Risk Management is embedded within these programmes to drive towards compliance.
A qualification in an Engineering/ Physical Science degree, proven relevant experience in an Engineering/Science related function, or significant proven experience within a regulated occupational environment.
Experience in the application of production and process controls including process validation, process control plans and statistical process control.
Experience in product development of complex systems (mechanical, electrical, and software).
Working knowledge and experience with ISO 9001.
Working knowledge and experience with ISO 13485, 21 CFR Part 820, IVDD 98/79/EC, MDD 93/42/EEC, IVDR 2017/746/EU and MDR 2017/745/E.
Working knowledge and experience with 21CFR820 Design Control, ISO62304, IEC62366-1 or equivalent is desired.
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.
Company Name: Waters Division
External Company URL: www.waters.com