The Director of Regulatory Compliance and Quality Assurance will be responsible for managing, organizing, and maintaining the Quality Assurance and Regulatory Compliance requirements in accordance with applicable domestic and foreign medical device regulations.
Key Activities
Implement and manage a complete quality program, including assuring compliance with US Food and Drug Administration (FDA) QSR requirements, ISO 13485 requirements, the State of California Department of Health requirements, applicable foreign regulatory requirements (such as Europe, Japan, China, Latin America, Australia and India), and ensure compliance with the contract specifications of OEM customers.
As Management Representative, responsible for the following per ISO 13485:2016: Ensuring the processes needed for the quality management system are documented; reporting to top management on the effectiveness of the quality management system and any need for improvement; and ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
Preferred Skills
Detailed knowledge within areas of specialty and assignments and broad understanding of other specialties that are involved in assigned projects.
Apply knowledge, using strong conceptualization and abstract reasoning skills at a high level of problem identification and solution.
Educations & Experience
10 years experience in Quality Assurance of medical device manufacturing (all activities from design, development, validation, production, servicing, and documentation) and Regulatory Compliance with domestic (US FDA) and preferably foreign regulatory requirements (e.g. ISO 13485, Chinese NMPA, Japanese PMDA, Australian TGA, Brazil ANVISA, India CDSCO, etc.).
Experience with orthopaedic devices (joint replacement and trauma) is HIGHLY PREFERRED.
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TQR is an equal-opportunity employer that encourages diversity. We will consider all applications.
Accommodation for applicants with disabilities is available upon request.
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We thank all applicants for their interest and appreciate the time and effort involved; however, due to the large volume of resumes received only those candidates selected for an interview will be contacted. Please attached your resume to your application.