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Senior Design Quality Assurance Engineer, Wilmslow
Client:
Waters Corporation Location:
Wilmslow, United Kingdom Job Category:
Other EU work permit required:
Yes Job Reference:
98d00904a909 Job Views:
9 Posted:
23.01.2025 Expiry Date:
09.03.2025 Job Description:
Overview Waters, the world's leading specialty measurement company that cares about inclusion and diversity, is seeking 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 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, ISO 62304, ISO 62366, ISO 14971. Collaborate with Design Quality Engineers, Clinical on design control requirements and approach. Provide interpretation guidance on industry best practices 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 Bachelor's 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. Demonstrated practical approach towards problem solving. Ability to work independently and as a member of a cross-functional team, to multi-task and prioritize 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 the organization. Company Description Waters Corporation (NYSE: WAT), the world's leading specialty measurement company, has pioneered chromatography, mass spectrometry, and thermal analysis innovations serving
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Client:
Waters Corporation Location:
Wilmslow, United Kingdom Job Category:
Other EU work permit required:
Yes Job Reference:
98d00904a909 Job Views:
9 Posted:
23.01.2025 Expiry Date:
09.03.2025 Job Description:
Overview Waters, the world's leading specialty measurement company that cares about inclusion and diversity, is seeking 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 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, ISO 62304, ISO 62366, ISO 14971. Collaborate with Design Quality Engineers, Clinical on design control requirements and approach. Provide interpretation guidance on industry best practices 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 Bachelor's 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. Demonstrated practical approach towards problem solving. Ability to work independently and as a member of a cross-functional team, to multi-task and prioritize 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 the organization. Company Description Waters Corporation (NYSE: WAT), the world's leading specialty measurement company, has pioneered chromatography, mass spectrometry, and thermal analysis innovations serving
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