{"id":2650020,"url":"https://alion.io/job/axogeninc-sr-engineer-supplier-quality","title":"Sr. Engineer, Supplier 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":105237,"currency":"USD","period":"year","gross":null,"usd_annual":105237},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[],"status":"live","first_seen_at":"2026-08-28T22:28:40Z","employer_posted_date":"2026-08-28","last_verified_at":"2026-10-19T07:52:40Z","board_verified":true,"closed_at":null,"days_open":51,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":51},"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, Supplier Quality\nThis 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.\nRequirements of the Sr. Engineer, Supplier Quality\nBachelor's degree in the sciences (biology, chemistry, biochemistry, or chemical engineering) with 5+ years of pharmaceutical or biopharmaceutical experience in a GMP environment.\nExperienced auditor with minimum 2 years auditing in pharmaceutical or medical device industry. Quality auditor certification is preferred.\nWorking experience managing a supplier quality management program.\nDemonstrated 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.\nExperience 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.\nIndependent decision making with a high degree of initiative.\nStrong oral and written communication, collaboration, and interpersonal skills with the ability to influence others, facilitate team interactions, and partner with key stakeholders.\nMotivated self-starter; detail and results-oriented.\nWell organized and efficient with ability to manage multiple priorities.\nInnovative thinker and problem solver\nResponsibilities of the Sr. Engineer, Supplier Quality\nThe specific duties of the Sr. Engineer, Supplier Quality include but are not limited to:\nManage the Supplier Quality Management Program for company contract service providers (CSPs) including the following:\nOversee the GMP Supplier Audit Program - Lead supplier audits, coordinate auditor assignments, and manage audit schedule, agendas, responses, reports, statuses, and audit closures.\nCreate, revise, approve, and maintain the Supplier Quality Agreements.\nMaintain the Approved Supplier List and supplier qualification statuses.\nCollaborate with Subject Matter Experts to support supplier selection.\nOrganize, archive, and maintain Supplier Audit Files and establish KPls and SQM metrics.\nReport on supplier performance to Quality management.\nRepresent SQM in external and internal audits, and on cross-functional teams and initiatives.\nTrain personnel on the SQM program.\nSupports change management by authoring impact assessments for changes to CSP services.\nProactively evaluate systems and processes to identify improvements with a focus to simplify and standardize. Lead and drive improvements as required.\nRevise and approve standard operating procedures and other controlled documents as necessary.\nSupports regulatory inspections and inspection readiness activities.\n\nLocation\n913 Industrial Drive Place, Vandalia, OH 45377\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—$105,237 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. Unsolicited résumés will not be considered.","description_format":"text","description_chars":7058,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["401k plan","Life insurance","Parental leave","Retirement plans"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":[],"lifecycle":[{"event":"open","at":"2026-10-15T21:22:14Z"}],"visa":[],"liveness":{"score":24,"band":"cold","label":"Long shot","p_open":1,"p_active":0.537,"p_room":0.45,"age_days":51,"expected_fill_days":26,"reasons":["conf:1","win:tail"],"computed_at":"2026-10-19T05:45:15Z"},"pay":{"stated_usd_annual":105237,"is_top_pay":false},"html_url":"https://alion.io/job/axogeninc-sr-engineer-supplier-quality","json_url":"https://alion.io/job/axogeninc-sr-engineer-supplier-quality.json","meta":{"generated_at":"2026-10-19T09:27:37Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":6562,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-20T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":4418165},"rest":"https://alion.io/mcp/rest/get_company?id=4418165"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Faxogeninc-sr-engineer-supplier-quality"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Faxogeninc-sr-engineer-supplier-quality"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Faxogeninc-sr-engineer-supplier-quality"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/axogeninc-sr-engineer-supplier-quality\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Faxogeninc-sr-engineer-supplier-quality"}]}