Summary from listing
The Senior Quality Engineer (Quality Systems) will lead, maintain, and improve the organization’s Quality Management System, including internal and external audits, CAPA management, nonconformance processes, quality metrics, procedures, and regulatory compliance. The role requires a relevant bachelor’s or licentiate degree, at least five years of medical device or pharmaceutical quality systems experience, strong root-cause analysis and technical writing skills, and knowledge of 21 CFR Part 820 and ISO 13485:2016.
