Experienced in post-market quality activities, the contract Senior Post Market Quality Engineer will investigate product complaints, support post-market surveillance, and participate in remediation projects for cardiovascular medical devices. Key responsibilities Investigate product complaints and perform root cause analysis Support Post Market Surveillance (PMS) activities and product performance monitoring Participate in remediation projects and corrective action initiatives Required qualifications Bachelor's degree in Engineering, Life Sciences, or a related field 6+ years of experience in the Medical Device industry Strong experience with Complaint Handling and Post Market Surveillance (PMS) Experience supporting Remediation projects Knowledge of FDA regulations, ISO 13485, CAPA, and risk management
Senior Post Market Quality Engineer • Anaheim, California, United States
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