Senior Quality Engineer - Medical Devices, Impact & Growth

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 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.