Sr. Engineer, Quality Complaint Management

About this role

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 Paid holidays, including floating holidays, to be used at your discretion Employee Stock Purchase Plan Referral incentive program 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 Sr. Engineer, Quality Complaint Management This position reports to the Sr. Manager, Quality Systems Compliance, and is responsible for the process management of the complaint system. This includes serving as the principle complaint investigator and managing performance of the system. Requirements of the Sr. Engineer, Quality Complaint Management Bachelor’s degree in a scientific or medical discipline required At least five years’ experience (three years’ with a Master’s degree or above) in the pharmaceutical or medical device industry required with a minimum of one year of experience working with medical device and/or pharmaceutical complaints Working experience managing a complaint system compliant 21 CFR 211, 600, 820, 1271 and international standards is preferred Independent decision-making with high initiative Strong oral and written communication, collaboration, and interpersonal skills with those from diverse technical backgrounds Well-organized, with the ability to efficiently manage multiple, competing priorities Ability to assess and apply risk management principles per ISO 14971 and ICH Q9 Responsibilities of the Sr.