Overview
Waters, the world's leading specialty measurement company that cares about inclusion and diversity is seeking for a Senior Design Quality Engineer, Clinical, to be located in Wilmslow,Manchester or Wexford, Ireland. 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.
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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, ISO 62304, ISO 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
- Significant 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.
- 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
- 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.
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.
Waters Wilmslow:
People create the Waters difference. By engaging with our talented and diverse workforce we continuously evolve, develop and enhance our products. Being the world's leading speciality measurement company, we believe in delivering innovative technology and system solutions to our valued customers to enable their success. At Wilmslow, our focus is on the development and delivery of mass spectrometry systems and software in a collaborative and dynamic team environment.
Our mass spectrometers deliver benefit to customers in many industries and make a meaningful impact to our lives through examples such as
- Neo-natal screening to keep babies healthy
- Ensuring consistent, reliable safety in our global food and water supply
- Developing new medicinal therapies to advance human health
- Ensuring participants in the world's sporting events compete fairly