Axogen Corporation
Director, Quality Assurance
Axogen Corporation, Vandalia, Ohio, United States, 45377
Axogen Corporation - Director, Quality Assurance - Vandalia, Ohio
Axogen is committed to building and maintaining a strong and gratifying company culture that fosters a work-life balance and 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 the leading company revolutionizing the science of nerve repair. We are passionate about helping to restore function and quality of life to patients with physical damage or discontinuity to peripheral nerves. Contribute to positively impacting lives while working for a company that respects, recognizes, and values all team members! 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 perspectivesCompany-wide dedication to profoundly impacting patients' livesComprehensive, high-quality benefits package effective on date of hireEducational assistance available for all employeesMatching 401(k) retirement planFlexible working hoursPaid holidays, including floating holidays, to be used at your discretionEmployee Stock Purchase PlanReferral incentive programIf you want to see how you can impact lives at Axogen, take a look at these inspiring patient stories:
Patient StoriesJob 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 requiredDemonstrated 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 auditsDemonstrate experience in successful hiring and management of a quality or related organization/group.Excellent oral and written communication skillsExcellent interpersonal and team-building skillsAbility to work independently, analyze and work with attention to detail, process and prioritize sensitive information and problem solveAbility to exercise creativity and judgmentExperience with human tissue products or implantable medical devices is desirableExperience with quality functions for biologics is requiredExperience with Six Sigma and/or Lean Manufacturing desirable complexFamiliar 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 include but are not limited to:Establishes and administers AxoGen's Quality Management SystemOversees all quality functions related to human tissue productsApply here
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Axogen is committed to building and maintaining a strong and gratifying company culture that fosters a work-life balance and 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 the leading company revolutionizing the science of nerve repair. We are passionate about helping to restore function and quality of life to patients with physical damage or discontinuity to peripheral nerves. Contribute to positively impacting lives while working for a company that respects, recognizes, and values all team members! 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 perspectivesCompany-wide dedication to profoundly impacting patients' livesComprehensive, high-quality benefits package effective on date of hireEducational assistance available for all employeesMatching 401(k) retirement planFlexible working hoursPaid holidays, including floating holidays, to be used at your discretionEmployee Stock Purchase PlanReferral incentive programIf you want to see how you can impact lives at Axogen, take a look at these inspiring patient stories:
Patient StoriesJob 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 requiredDemonstrated 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 auditsDemonstrate experience in successful hiring and management of a quality or related organization/group.Excellent oral and written communication skillsExcellent interpersonal and team-building skillsAbility to work independently, analyze and work with attention to detail, process and prioritize sensitive information and problem solveAbility to exercise creativity and judgmentExperience with human tissue products or implantable medical devices is desirableExperience with quality functions for biologics is requiredExperience with Six Sigma and/or Lean Manufacturing desirable complexFamiliar 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 include but are not limited to:Establishes and administers AxoGen's Quality Management SystemOversees all quality functions related to human tissue productsApply here
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