Position Summary:
As a key member of the Quality team, the Senior Quality Assurance Engineer ensures the Quality Management System (QMS) complies with all applicable regulations and standards. This role is responsible for maintaining and enhancing the Corrective and Preventive Action (CAPA) system in collaboration with cross-functional teams, as well as leading validation activities for quality system software.
Duties & Responsibilities:
- Ensure compliance of the QMS with 21 CFR Part 820, ISO 13485:2016, EU MDR, MDSAP, and other applicable regulatory requirements.
- Develop, maintain, and improve Standard Operating Procedures (SOPs), forms, and templates across the organization.
- Manage the electronic CAPA system and oversee its implementation.
- Lead CAPA Review Board meetings and ensure the overall effectiveness of the CAPA process.
- Review CAPA investigations and action plans to ensure completeness, accuracy, and timely execution.
- Monitor and track the implementation of corrective and preventive actions for continuous process improvement.
- Lead validation activities for existing and new QMS software in compliance with 21 CFR Part 11.
- Define specifications, requirements, and acceptance criteria for non-product software validation.
- Develop validation deliverables including test plans, test cases, and final reports.
- Support external audits and inspections (e.g., FDA, notified body) as required.
- Lead or contribute to internal quality audits.
- Track and report key quality metrics (e.g., nonconformances, audit findings, complaints).
- Generate reports and presentations to inform leadership and support strategic quality initiatives.
- Other duties as needed or required.
