A large, global medical device company in Irvine has opportunities for Post Market Surveillance Engineers. Duties:The Post Market Surveillance Quality Engineer I will provide engineering support for PMS system to collect and perform trend analysis assessing the following data sources on products: adverse events, complaints, product feedback, customer requirements and market needs, patient follow-up after clinical trials/investigations, service reports, scientific papers in peer-reviewed journals, reports on similar products by competitors, Field Corrective Action, CAPA, NCR and SCAR review and changes to relevant standards and regulations. This PMS Quality Engineer will also be focused on activities associated with the implementation of the EU Medical Device Regulation (MDR) Program.
Additional Skills: • Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment required • Proven expertise in MS Office Suite and ability to operate general office machinery • Excellent written and verbal communication skills and interpersonal relationship skills • Demonstrated problem-solving , critical thinking, and investigative skills • Full knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance • Good knowledge of medical terms and human anatomy • Full knowledge of Medical Device Reporting regulations, and regulatory reporting regulations • Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing • Ability to manage confidential information with discretion • Attention to detail • Ability to interact professionally with all organizational levels • Ability to manage competing priorities in a fast paced environment • Work is performed independently on complex work and reviewed for accuracy and soundness
Education and Experience: A Bachelor’s Degree or equivalent in Engineering field with a minimum of 1-2 years of related experience dealing with regulatory or quality assurance issues in the medical device or pharmaceuticals industries.
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