Sr. Engineer, Quality

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

Benefits offered by this job

Health benefits

Dental benefits

Vision benefits

401K matching

Paid time off

9 paid holidays + floating holidays

Employee stock purchase plan

Job summary

Axogen seeks a Sr. Engineer, Quality to provide quality and compliance support for development, manufacture, and distribution of healthcare products.

The role requires independent judgment, strong project management, and leadership across cross‑functional teams to ensure conformity with regulatory standards. Requirements include a BS in Biomedical/Mechanical Engineering or related field, 5+ years in quality roles for medical devices, and experience with statistics, FMEA, and design control.

Qualifications

• Bachelor's degree in Biomedical, Mechanical Engineering, or Engineering Technology with Lean/Progressive Manufacturing and Quality disciplines.
• Strong project management skills.
• Fundamental understanding of design controls and manufacturing practices.
• 5+ years in a Quality Engineering/Quality Assurance role for medical device/pharma manufacturing.
• Proficient with MS Office suite including Visio and Project.
• Experience with FMEA, statistics, and data analysis.

Responsibilities

• Confer with internal and external departments on product design to meet user needs.
• Evaluate design for manufacturability and suggest improvements.
• Lead qualification/validation of tools, fixtures, and equipment in manufacturing.
• Lead quality planning for new product development projects and validation plans.
• Collaborate with supply chain partners to assure product quality.

Skills

Project management

Statistics

MS Office

Quality engineering

Education

Bachelor of Science in Biomedical/Mechanical Eng or Eng Tech

Tools

Minitab

Microsoft Visio

Microsoft Project

Job description

Axogen Culture

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. The Sr. Engineer may have a small group of direct reports and uses skills to contribute to development of company objectives.

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 (example 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

• 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

APC

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 - $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.