Summary from listing
The Interventional Urology Operations Associate Quality Engineer supports and maintains quality compliance for US Operations, with a primary focus on patient safety and product quality. Responsibilities include FDA/ISO compliance support, quarantining and disposing of non-conforming products, leading root-cause analysis and corrective and preventive actions, participating in MRB meetings, supporting complaint investigations, managing change controls, preparing quality documentation, and performing data analysis. The role requires a bachelor’s degree in engineering or a related field, 0–2+ years of related manufacturing or relevant experience, strong analytical and communication skills, and knowledge of FDA, QSMR, ISO 13485, and ISO 14971 requirements. Compensation is $73,767–$110,650, with medical, dental, and vision insurance and other benefits.
