Responsibilities Assume a Subject Matter Expert (SME) role on Product Development process activities and related workflows in relation to regulatory compliance, provide 'solution-based' problem resolutionAct 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.Mentor to Design Quality Engineers, Clinical on design control requirements and approachProvide interpretation guidance and mentorship 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 including risk management, maintenance, configuration management and problem resolution.
Qualifications EducationMinimum of a Bachelors Degree required.
Chemistry, Medical or Science Graduate education is preferableExperienceExtensive 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.Extensive 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, 510KCompetenciesStrong leadership, coaching and mentoring skills.Strong ability to lead staff dispersed across many different locations and culturesStrong organization/prioritization skillsExceptional 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.Strong analytical skills with the ability to identify, diagnose, and solve problems with minimal direction and make decisions with confidence