Sr. Engineer, Supplier Quality at Axogen in Vandalia, OH

Job description

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, Supplier Quality This position reports to the Staff Engineer I, Supplier Quality and is responsible for the implementation, management, and compliance of the GxP Supplier Quality Management (SQM) Program, Supplier Audits, and Quality Agreements. This role ensures a robust and compliant SQM process that complies with FDA, EMA, Health Canada, ISO, and other applicable regulatory requirements and company procedures. The position is responsible for executing the SQM strategy and facilitating SQM integration with cross- functional processes. The role will also provide Quality Assurance support and oversight to contract service provider selection and qualification processes. Requirements of the Sr. Engineer, Supplier Quality Bachelor's degree in the sciences (biology, chemistry, biochemistry, or chemical engineering) with 5+ years of pharmaceutical or biopharmaceutical experience in a GMP environment. Experienced auditor with minimum 2 years auditing in pharmaceutical or medical device industry. Quality auditor certification is preferred. Working experience managing a supplier quality management program. Demonstrated understanding of Quality principles, industry practices, and standards (21 CFR, ISO, GxP, ICH, etc.) and ability to apply these to GxP operations internally and contract service providers. Experience with commercial drug product operations including biologics, finished goods production, API and excipient manufacturing, and analytical testing. Combination product or medical device experience is a plus. Independent decision making with a high degree of initiative. Strong oral and written communication, collaboration, and interpersonal skills with the ability to influence others, facilitate team interactions, and partner with key stakeholders. Motivated self-starter; detail and results-oriented. Well organized and efficient with ability to manage multiple priorities. Innovative thinker and problem solver Responsibilities of the Sr. Engineer, Supplier Quality The specific duties of the Sr. Engineer, Supplier Quality include but are not limited to: Manage the Supplier Quality Management Program for company contract service providers (CSPs) including the following: Oversee the GMP Supplier Audit Program - Lead supplier audits, coordinate auditor assignments, and manage audit schedule, agendas, responses, reports, statuses, and audit closures. Creat