Description
Position Overview
We are seeking a Quality Engineer to support post-market quality activities within a regulated environment. This individual will play a key role in ensuring product quality and regulatory compliance through post-market surveillance, CAPA activities, and cross-functional collaboration.
Key Responsibilities
Support post-market quality engineering activities across commercially released products
Lead and contribute to CAPA investigations; ensure timely closure and effectiveness checks
Review and maintain risk management documentation in alignment with regulatory standards
Analyze product performance trends; identify and escalate quality issues as needed
Partner cross-functionally with engineering, regulatory, manufacturing, and clinical teams
Ensure compliance with applicable FDA, ISO, and internal quality system requirements
Support product launches and ongoing lifecycle quality initiatives
Skills
Quality engineering, post...