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Senior Quality Assurance Engineer
2 months ago
We are seeking a highly skilled Senior Quality Assurance Engineer to join our team at Waters Corporation. As a key member of our quality team, you will be responsible for ensuring the design and development of our medical devices meet the highest standards of quality and regulatory compliance.
Responsibilities- Assume a Subject Matter Expert (SME) role on Product Development process activities and related workflows in relation to regulatory compliance, providing solution-based problem resolution.
- Act as Quality specialist in relation to design and development, ensuring conformance and up-to-date information on applicable regulatory requirements, including ISO 9001, ISO 13485, 21 CFR parts 11 and 820, ISO 62304, ISO 62366, and ISO 14971.
- Mentor Design Quality Engineers, Clinical on design control requirements and approach.
- Provide 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, including planning, requirements, architecture, verification/validation, including risk management, maintenance, configuration management, and problem resolution.
- Minimum of a Bachelor's Degree required. Chemistry, Medical, or Science Graduate education is preferable.
- Extensive 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, and 510K.
- Strong leadership, coaching, and mentoring skills.
- Strong ability to lead staff dispersed across many different locations and cultures.
- Strong organization/prioritization skills.
- Exceptional interpersonal skills, using written and oral communication, for example, to ensure succinct report generation, effective communication with stakeholders, peer groups, etc., across the organization.
- Strong analytical skills with the ability to identify, diagnose, and solve problems with minimal direction and make decisions with confidence.
