Quality Systems Engineer

Roles & Responsibilities: Supports the overall QMS processes for the organization. Responsible for activities required to ensure compliance of Quality Management Systems (QMS), specifically regarding CAPA, complaints and internal/external audits. Additional responsibilities include supporting other QMS functions such as NCMRs, Supplier Controls, Management Review, Risk Review, etc. Execution and coordination of activities associated with CAPA program, including administration and record management, providing quality input to investigations, reporting, as well as metrics and trending Support CAPA Owners in quality-related technical principles, including but not limited to Problem Solving tools and techniques (Root Cause Analysis, DOE, FMEA, etc.) Education & Experience: Bachelor's Degree in Engineering, Biomedical Science, or other technical discipline preferred, with 3-6 years of relevant experience in medical device industry, including responsibility for Product Quality and/or Quality Systems Must have Medical Device experience in most recent roles A working knowledge of Quality System Standards and regulations, including 21 CFR Part 820, ISO 13485, EU MDR

Created: 2026-04-02