Sr. Engineer, Quality

axogen; Vandalia (OH); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Friendly team culture

Impact patients' lives

Benefits from day one

Educational assistance

401(k) matching

Paid holidays including floating days

Employee Stock Purchase Plan

Referral incentive program

Job summary

Axogen is seeking a Sr. Quality Engineer to provide quality and compliance support for the development, manufacture and distribution of healthcare products in accordance with global quality regulations. The role requires independent judgment in engineering methods and may supervise a small team.

The position emphasizes design controls, risk management, supplier collaboration, and strong project management to ensure quality systems and regulatory readiness across the product lifecycle.

Qualifications

• Bachelor of Science degree in Biomedical, Mechanical Engineering, or Engineering Technology.
• Minimum 5 years in a Quality Engineering/Quality Assurance role for medical device or pharmaceutical manufacturing.
• Strong project management and communication skills.
• Knowledge of design controls and regulatory requirements (21 CFR parts 820/1271, ISO 13485, ISO 9001, ISO 14971).
• Experience with statistical methods and data analysis tools (e.g., Minitab).
• Experience with GD&T and supplier quality activities.

Responsibilities

• Confer with product development, operations, and other departments on design to ensure user needs are met.
• Evaluate design for manufacturability and implement quality improvements.
• Lead selection, development, and validation of tools, fixtures, and equipment.
• Lead risk management activities and major quality issue resolutions.
• Ensure design control and transfer to production are effective.
• Lead quality planning for new product development and for facility/development projects.
• Investigate processes to reduce non-conformances and optimize inspections.

Skills

Quality engineering

Project management

Root cause analysis (DMAIC)

Statistical analysis

Design controls knowledge

Cross-functional collaboration

MS Office basics (Visio/Project)

Education

Bachelor of Science in Biomedical Engineering

Bachelor of Science in Mechanical Engineering

Engineering Technology degree

Tools

MS Office Suite (Visio, Project)

Minitab

GD&T

FMEA

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. 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 releva