Responsibilities
1. 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.
2. Collaborate with Design Quality Engineers, Clinical on design control requirements and approach
3. 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.
4. Evaluate the acceptability of products for release, ensuring customer requirements /specifications and internal Waters policies and procedures are met.
5. 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.
6. 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
Education
7. Minimum of a Bachelors Degree required. Chemistry, Medical or Science Graduate education is preferable
Experience
8. 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.
9. Desired - demonstrable experience in the application of design controls and risk management including design transfer, process validation and process control plans.
10. Desired – product development in a medical device environment
Competencies
11. Demonstrated practical approach towards problem solving
12. 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.
13. Strong organization/prioritization skills
14. 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.
15. Computer literate, preferably with knowledge of software packages such as Microsoft 365, Atlassian, SAP.