QA Manager – Medical Devices & Compliance

axogen; Vandalia (OH); On-site; USD 114,000 - 142,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

Matching 401K

Paid Time Off

Tuition Reimbursement

Employee Stock Purchase Plan

Job summary

Axogen in Vandalia, OH is seeking a Manager of Quality Assurance to lead QA operations across processing and distribution sites. You will establish and maintain QA processes, partner with Operations, and drive continuous improvement to ensure compliance with cGMP and ISO standards.

The role requires 5+ years in QA within medical devices or biotech, plus strong leadership, regulatory audit experience, and problem-solving skills. Travel up to 10% is possible.

Qualifications

• Bachelor’s Degree in Life Science or Engineering or related field.
• Minimum 5 years Quality Engineering/Quality Assurance in medical device/pharma/biotech manufacturing.
• Minimum 3 years of leading others or project management experience.

Responsibilities

• Manages Quality Assurance operations at DPC, APC, or BDC ensuring compliance with domestic and international quality standards.
• Establishes, implements, and maintains Axogen’s Quality Management Systems (QMS) aligned with cGMP, cGDP, QSR, ISO13485, MDD, AATB.
• Recruits, develops, and leads QA team members and builds high-performing teams.

Skills

Quality system leadership

Regulatory knowledge

Problem solving

Communication skills

Project management

Team leadership

Education

Bachelor’s Degree in Life Science or Engineering

Certified Quality Engineer preferred

Tools

MS Office Suite

SmartSheet

Visio

Project

Job description

Axogen in Vandalia, OH is seeking a Manager of Quality Assurance to lead QA operations across processing and distribution sites. You will establish and maintain QA processes, partner with Operations, and drive continuous improvement to ensure compliance with cGMP and ISO standards.

The role requires 5+ years in QA within medical devices or biotech, plus strong leadership, regulatory audit experience, and problem-solving skills. Travel up to 10% is possible.