Sr. Engineer, Supplier Quality

Axogen, Inc.; Vandalia (OH); On-site; USD 84,000 - 105,000; Full time

Benefits offered by this job

Annual bonus

Health insurance

Dental insurance

Vision insurance

Matching 401(k) retirement plan

Paid time off

9 paid holidays + 3 floating holidays

Education reimbursement

Parental leave

Stock Purchase Plan

Life Insurance

Disability Insurance

Job summary

Axogen, Inc. is seeking a Staff Engineer I, Supplier Quality, to lead and manage the GxP SQM program, supplier audits, and quality agreements. The role ensures robust compliance with FDA/EMA/ISO standards and guides cross-functional processes across the supply chain.

You will oversee supplier audits, maintain qualification statuses, and support regulatory inspections while collaborating with subject matter experts to improve SQM performance.

Qualifications

• Bachelor's degree in the sciences with 5+ years of pharmaceutical or biopharmaceutical GMP experience.
• 2+ years auditing experience in pharma/medical device sectors.
• Quality auditor certification preferred.
• Experience managing a supplier quality management program.
• Knowledge of 21 CFR, ISO, GxP, ICH and related standards.

Responsibilities

• Oversee GMP Supplier Audit Program; lead audits and manage schedules, reports, and closures.
• Create, revise, and maintain Supplier Quality Agreements.
• Maintain Approved Supplier List and qualification statuses.
• Collaborate with SMEs to support supplier selection.
• Maintain audit files and establish SQM metrics.
• Report supplier performance to Quality management.
• Represent SQM in audits and cross-functional initiatives.
• Train personnel on the SQM program.
• Support regulatory inspections and change management.

Skills

Auditing

Quality assurance

GxP

Regulatory knowledge

Communication

Initiative

Project management

Team collaboration

Problem solving

Education

Bachelor's degree in sciences

Job description

Company Culture & Equality

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

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

• 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

• 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 #LI-AC1

Benefits & Compensation

This position is eligible for an annual bonus.

• Health
• Dental
• Vision
• Matching 401(k) retirement plan
• 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
• Disability Insurance

as described in more detail in summary plan descriptions.

Salary Range$84,190 - $105,237 USD

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

No 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.