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.

• 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.

<h3 class="rh-display-3--rich-text">TalentMatch®</h3> Robert Half is the world’s first and largest specialized talent solutions firm that connects highly qualified job seekers to opportunities at great companies. We offer contract, temporary and permanent placement solutions for finance and accounting, technology, marketing and creative, legal, and administrative and customer support roles. Robert Half works to put you in the best position to succeed. We provide access to top jobs, competitive compensation and benefits, and free online training. Stay on top of every opportunity - whenever you choose - even on the go. <a href="https://www.roberthalf.com/us/en/mobile-app" target="_blank">Download the Robert Half app</a> and get 1-tap apply, notifications of AI-matched jobs, and much more. All applicants applying for U.S. job openings must be legally authorized to work in the United States. Benefits are available to contract/temporary professionals, including medical, vision, dental, and life and disability insurance. Hired contract/temporary professionals are also eligible to enroll in our company 401(k) plan. Visit <a href="https://roberthalf.gobenefits.net/" target="_blank">roberthalf.gobenefits.net</a> for more information. © 2025 Robert Half. An Equal Opportunity Employer. M/F/Disability/Veterans. By clicking “Apply Now,” you’re agreeing to Robert Half’s <a href="https://www.roberthalf.com/us/en/terms">Terms of Use</a> and <a href="https://www.roberthalf.com/us/en/privacy">Privacy Notice</a>.

Simi Valley, CA
onsite
Contract / Temporary to Hire
47.58 - 55.09 USD / Hourly
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.
2026-01-28T21:14:04Z