{"id":2649999,"url":"https://alion.io/job/axogeninc-sr-engineer-quality","title":"Sr. Engineer, Quality","company":{"id":4418165,"name":"Axogen","domain":"axogeninc.eu","url":"https://alion.io/company/axogeninc-2","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Vandalia, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":84190,"max":110000,"currency":"USD","period":"year","gross":null,"usd_annual":110000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-08-31T16:11:23Z","employer_posted_date":"2026-10-13","last_verified_at":"2026-10-18T11:36:07Z","board_verified":true,"closed_at":null,"days_open":47,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":47},"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! \nAxogen 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. \n Why you’ll love working at Axogen: \nFriendly, open, and fun team culture that values unique perspectives \nCompany-wide dedication to profoundly impacting patients’ lives \nComprehensive, high-quality benefits package effective on date of hire \nEducational assistance available for all employees \nMatching 401(k) retirement plan \nPaid holidays, including floating holidays, to be used at your discretion \nEmployee Stock Purchase Plan \nReferral incentive program \nAxogen Mission and Business Purpose\nOur 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.\nJob Summary of the Sr. Engineer, Quality\nThe 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. \nRequirements of the Sr. Engineer, Quality\nMinimum of Bachelor of Science Degree in Biomedical, Mechanical Engineering, or Engineering Technology\nLean/Progressive Manufacturing and Quality disciplines \nFundamental understanding of design controls, project management, and basic manufacturing practices/processes\nMinimum of 5 years in a Quality Engineering/Quality Assurance role for medical device or pharmaceutical manufacturing\nStrong project management skills required\nDemonstrated knowledge of statistical sampling and analysis\nDemonstrated excellent organizational, writing and verbal communication skills\nProficient with the MS Office Suite, including Microsoft Visio and Project.\nLimit gauge design for dimensional verification\nProblem solving using root cause methodologies (i.e. DMAIC)\nApplying statistics and software in data analysis (i.e. Minitab)\nApplication of failure modes and effects analysis (FMEA)\nWorking with suppliers to design inspection systems and resolve quality issues\nQuality system regulations and requirements (examples 21 CFR part 820, 21 CFR Part 1271, 21 CFR Part 210/211, ISO 13485, ISO 9001, ISO 14971)\nGeometric Dimensioning and Tolerance (GD&T) experience\nDesirable but not required:ASQ Certified Quality Engineer\nLead auditor certification\nSix Sigma Black belt\n\nTravel Requirements are up to 30%\nResponsibilities of the Sr. Engineer, Quality\nThe specific duties of the Sr. Engineer, Quality include but are not limited to:\nConfer with external and internal departments (example Product Development, Clinical, Marketing, Sales, and Operations) concerning product design to ensure user needs are met.\nEvaluate product design for manufacturability and suggest design process adjustments and quality improvements.\nEngage in the selection, development, and qualification/validation of tools, fixtures, machinery, and equipment used in manufacturing.\nLead and participate in risk management activities.\nLead Quality issue resolution by applying root cause methodologies.\nEnsure effective design control and transfer to production.\nLead Quality Planning activities for new product development projects, including verification and validation plans and reliability strategies.\nLead Quality Planning activities in Facility development including verification and validation plans and reliability strategies.\nLead Quality Planning activities for new and existing processes, including verification and validation plans and reliability strategies.\nInvestigate manufacturing processes for non-conformance reduction and inspection optimization.\nDetermines quality improvement parameters by identifying statistical methods relevant to manufacturing processes.\nPrepares reports and presentations by collecting, analyzing, and summarizing data; making recommendations.\nMaintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies.\nCollaborate with supply chain partners to assure quality of product.\nConfer with purchasing and logistics to maintain the supplier management program.\nDesign and implement inspection methods, equipment, acceptance criteria and sampling plans.\nInitiate or assist in cost reductions of product inspections.\nProvide validation, sampling, and statistical analysis support to other functions in the organization.\nPerform First Article Inspections to ensure Manufacturing process capability.\nEnsure compliance with CGMP, QSR, ISO13485, MDD, and other applicable regulations/standards.\nParticipate in FDA inspections, ISO Certification, surveillance audits and customer audits.\nDeploying proactive quality controls for consistent and predictable quality outcomes.\nEstablish and implement metrics for monitoring system effectiveness.\nReport to management on quality issues, trends and losses.\nProvide functional support as needed for all team members.\nDirect staff as needed.\nLocation\nVandalia, OH\nBenefits/Compensation\nThis position is eligible for an annual bonus.\nBenefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 3 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance, as described in more detail in summary plan descriptions.\nSalary Range\n$84,190—$110,000 USD\nCompany Statements\nAxogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.\nAs AI is becoming a common tool throughout the application process, we want to be clear about its appropriate use at Axogen. Using AI to support resume writing, research or interview preparation is perfectly acceptable, provided the content is accurate and genuinely represents your qualifications and skills. For other key parts of your interview process, however, it is important that the ideas, communication, and work you share reflect your own voice, experiences, and thinking. We ask that you participate in our live interviews and complete any assessments without AI assistance unless instructions explicitly indicate otherwise or a specific exception is discussed and approved in advance. This approach ensures fairness, celebrates your individuality, and allows your authentic perspective to shine. Behaviors that do not align with these guidelines may result in disqualification from the hiring process or termination of employment if later discovered. We appreciate your understanding and look forward to learning about the unique contributions only you can bring to Axogen.\nNo agency solicitation. We kindly request that recruiting agencies, staffing firms, and third-party vendors do not contact us regarding this posting. 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