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Axogen

Sr. Engineer, Quality

Vandalia, OH, United States

$84,190 - $115,000 USD

Apply on axogeninc.com About employer

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Job details

Pay: $84,190 - $115,000 USD
Posting language: English
Posted: Nov 11, 2026

Original job 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!

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 1271, 21 CFR Part 210/211, ISO 13485, ISO 9001, ISO 14971)
Geometric Dimensioning and Tolerance (GD&T) experience
Desirable but not required:
ASQ Certified Quality Engineer
Lead auditor certification
Six Sigma Black belt
Travel Requirements are up to 30%

Responsibilities of the Sr. Engineer, Quality

The specific duties of the Sr. Engineer, Quality include but are not limited to:

Confer with external and internal departments (example Product Development, Clinical, Marketing, Sales, and Operations) concerning product design to ensure user needs are met.
Evaluate product design for manufacturability and suggest design process adjustments and quality improvements.
Engage in the selection, development, and qualification/validation of tools, fixtures, machinery, and equipment used in manufacturing.
Lead and participate in risk management activities.
Lead Quality issue resolution by applying root cause methodologies.
Ensure effective design control and transfer to production.
Lead Quality Planning activities for new product development projects, including verification and validation plans and reliability strategies.
Lead Quality Planning activities in Facility development including verification and validation plans and reliability strategies.
Lead Quality Planning activities for new and existing processes, including verification and validation plans and reliability strategies.
Investigate manufacturing processes for non-conformance reduction and inspection optimization.
Determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes.
Prepares reports and presentations by collecting, analyzing, and summarizing data; making recommendations.
Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies.
Collaborate with supply chain partners to assure quality of product.
Confer with purchasing and logistics to maintain the supplier management program.
Design and implement inspection methods, equipment, acceptance criteria and sampling plans.
Initiate or assist in cost reductions of product inspections.
Provide validation, sampling, and statistical analysis support to other functions in the organization.
Perform First Article Inspections to ensure Manufacturing process capability.
Ensure compliance with CGMP, QSR, ISO13485, MDD, and other applicable regulations/standards.
Participate in FDA inspections, ISO Certification, surveillance audits and customer audits.
Deploying proactive quality controls for consistent and predictable quality outcomes.
Establish and implement metrics for monitoring system effectiveness.
Report to management on quality issues, trends and losses.
Provide functional support as needed for all team members.
Direct staff as needed.

Location

913 Industrial Park Dr, Vandalia, OH 45377

Benefits/Compensation This position is eligible for an annual bonus.

Benefits 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.

Salary Range

$84,190 - $115,000 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. 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.

Apply on axogeninc.com About employer

More about this job

Skills

Regulatory compliance
Quality assurance procedures
Mechanical engineering
Project management
Quality assurance
Pharmaceutical processes
Communication skills
Microsoft Office
Microsoft Visio
Problem solving
Statistics
Data analysis
Minitab
Inspection
ISO 9001
Lean Six Sigma Black Belt
Sales
Develop product design
Design process
Risk management
Manufacturing processes
Presentation skills
Supply chain management
Procurement
Logistics
Vendor management
Guide staff

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Work requirements

Jobs in the United States