Job Information
Axogen Corporation Director, Quality Assurance in Vandalia, Ohio
Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one! Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status. Why you'll love working at Axogen: * Friendly, open, and fun team culture that values unique perspectives * Company-wide dedication to profoundly impacting patients' lives * Comprehensive, high-quality benefits package effective on date of hire * Educational assistance available for all employees * Matching 401(k) retirement plan * Flexible working hours * Paid holidays, including floating holidays, to be used at your discretion * Employee Stock Purchase Plan * Referral incentive program If you want to see how you can impact lives at Axogen, take a look at these inspiring patient stories: https://www.axogeninc.com/patient-stories/ Axogen Mission and Business Purpose Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care. Job Summary of the Director, Quality Assurance The Director, Quality Assurance will be a key member of the AxoGen Leadership team with responsibility for establishing and administering all Quality functions related to cGXX (cGMP, QSR and cGTP) operations. The Director, Quality Assurance will provide quality oversight and support AxoGen's manufacturing, processing, testing and product distribution functions. The position requires domestic and international travel, primarily to AxoGen locations to ensure compliance with domestic and international regulations. Requirements of the Director, Quality Assurance * BA, MS or PhD with at least 10 years' experience in a quality assurance or related role in the biologics or pharmaceutical industry is required * Demonstrated knowledge of cGXXs and relevant regulatory guidelines in the US and OUS. * Familiarity with ISO 13485 requirements for the design and manufacture of medical devices. * Experience at all phases of development, including commercialization. * Experience in leading external regulatory audits * Demonstrate experience in successful hiring and management of a quality or related organization/group. * Excellent oral and written communication skills * Excellent interpersonal and team-building skills * Ability to work independently, analyze and work with attention to detail, process and prioritize sensitive information and problem solve * Ability to exercise creativity and judgment * Experience with human tissue products or implantable medical devices is desirable * Experience with quality functions for biologics is required * Experience with Six Sigma and/or Lean Manufacturing desirable complex * Familiar with preparation of and guidelines for Chemistry, Manufacturing, and Controls (Module 3) worldwide regulatory submissions desirable. Responsibilities of the Director, Quality Assurance The specific duties of tApply here: https://www.aplitrak.com/?adid=YmJnZW5lcmljLjc4MjIwLjEwNTA4QGF4b2dlbmluY2NvbXAuYXBsaXRyYWsuY29t