Sr. Engineer, Supplier 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 youll love working atAxogen:

• Friendly openandfunteam culturethat values uniqueperspectives
• Company-wide dedicationto profoundly impacting patients lives
• Comprehensive high-quality benefitspackage effective on date of hire
• Educationalassistanceavailable for all employees
• Matching 401(k)retirementplan
• Paid holidaysincluding floating holidaysto 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

• Bachelors 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.
  • Create revise approve and maintain the Supplier Quality Agreements.
  • Maintain the Approved Supplier List and supplier qualification statuses.
  • Collaborate with Subject Matter Experts to support supplier selection.
  • Organize archive and maintain Supplier Audit Files and establish KPls and SQM metrics.
  • Report on supplier performance to Quality management.
  • Represent SQM in external and internal audits and on cross-functional teams and initiatives.
  • Train personnel on the SQM program.
  • Supports change management by authoring impact assessments for changes to CSP services.
  • Proactively evaluate systems and processes to identify improvements with a focus to simplify and standardize. Lead and drive improvements as required.
  • Revise and approve standard operating procedures and other controlled documents as necessary.
  • Supports regulatory inspections and inspection readiness activities.

Location

913 Industrial Drive Place Vandalia OH 45377

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Benefits/Compensation

Company Statements

Axogen 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.

As 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.

No agency solicitation. We kindly request that recruiting agencies staffing firms and thirdparty vendors do not contact us regarding this posting. Unsolicited résumés will not be considered.