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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.
Job Responsibility:
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
Requirements:
Minimum of 3 years of experience in quality assurance within a medical device manufacturing environment
Hands-on experience with ISO 13485-compliant Quality Management Systems
Proficiency in Selenium for web browser automation and manual testing
Strong knowledge of quality assurance practices, including testing and regulatory compliance
Demonstrated ability to conduct audits and manage document control processes effectively
Familiarity with complaint handling and post-market surveillance activities
Proven track record of submitting regulatory reports and managing device licenses
Excellent analytical and organizational skills with a focus on data-driven decision-making