Sr. Engineer, Quality

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 The Sr. Quality Engineer will provide Quality and Compliance related support for the development, manufacture and distribution of healthcare products in accordance with applicable Quality Management regulations (International and Domestic regulations for Biologic, Human Tissue, Medical Device products) The Sr. Engineer exercises independent judgment in engineering methods, techniques and evaluation criteria for obtaining results, creates formal networks involving coordination among groups, and has broad expertise or unique knowledge in Engineering. Requirements of the Sr. Engineer, Quality * Minimum of Bachelor of Science Degree in Biomedical, Mechanical Engineering, or Engineering Technology * Lean/Progressive Manufacturing and Quality disciplines * Fundamental understanding of design controls, project management, and basic manufacturing practices/processes * Minimum of 5 years in a Quality Engineering/Quality Assurance role for medical device or pharmaceutical manufacturing * Strong project management skills required * Demonstrated knowledge of statistical sampling and analysis * Demonstrated excellent organizational, writing and verbal communication skills * Proficient with the MS Office Suite, including Microsoft Visio and Project. * Limit gauge design for dimensional verification * Problem solving using root cause methodologies (i.e. DMAIC) * Applying statistics and software in data analysis (i.e. Minitab) * Application of failure modes and effects analysis (FMEA) * Working with suppliers to design inspection systems and resolve quality issues * Quality system regulations and requirements (examples 21 CFR part 820, 21 CFR Part 1