We are looking for an experienced Quality Assurance Manager to join our team in Simi Valley, California. in this position you will play a pivotal role in ensuring the development, implementation, and maintenance of a robust ISO 13485-compliant Quality Management System within a regulated medical device manufacturing environment. This role requires close collaboration with cross-functional teams to uphold product quality standards, meet regulatory requirements, and drive continuous improvement initiatives.Responsibilities:• Serve as the Management Representative, overseeing all aspects of quality system compliance.• Coordinate and manage internal and external audits to ensure adherence to regulatory standards.• Train staff on quality procedures and regulatory requirements to enhance overall compliance.• Handle product recalls, from initiation to closure, while maintaining accurate and compliant recall files.• Conduct post-market surveillance activities and maintain Device Master Records to ensure product safety.• Submit reportable events promptly in accordance with applicable regulatory guidelines.• Renew medical device licenses and registrations for relevant jurisdictions.• Prepare management review presentations, analyze quality metrics, and identify trends to support process improvements.• Manage the document change order process, ensuring updates to procedures and inspection documents are implemented and recorded accurately.
