Senior Supplier Quality Engineer - Audits & Compliance

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

Benefits offered by this job

Health insurance

Dental insurance

Vision

Matching 401K

Paid time off

9 paid holidays + 3 floating holidays

Employee stock purchase plan

Job summary

Axogen is seeking a Sr. Engineer, Supplier Quality in Vandalia, OH to own the GxP SQM program, drive supplier audits, and ensure regulatory compliance across FDA/ISO standards. You will manage SQM processes for CSPs, develop quality agreements, and oversee supplier qualifications.

The role requires 5+ years in pharma/biopharma GMP, strong audit experience, and the ability to lead cross-functional initiatives. Eligible for annual bonus; benefits on day one.

Qualifications

• Bachelor’s degree in the sciences with 5+ years of pharmaceutical/biopharmaceutical GMP experience.
• Minimum 2 years auditing experience in pharma/medical device industries; auditor certification preferred.
• Experience managing a supplier quality management program.

Responsibilities

• Lead the GMP Supplier Audit Program; oversee audits, schedules, and closures.
• Create, revise and maintain Supplier Quality Agreements.
• Maintain Approved Supplier List and qualification statuses; collaborate with SMEs for supplier selection.
• Support CSP supplier selection and qualifications; train personnel on SQM program.
• Drive improvements; revise SOPs and controlled documents; support inspections.

Skills

Auditing experience

Supplier quality management

Quality systems

Regulatory knowledge

Education

Bachelor's degree in sciences

Tools

GxP compliance tools

Job description

Axogen is seeking a Sr. Engineer, Supplier Quality in Vandalia, OH to own the GxP SQM program, drive supplier audits, and ensure regulatory compliance across FDA/ISO standards. You will manage SQM processes for CSPs, develop quality agreements, and oversee supplier qualifications.

The role requires 5+ years in pharma/biopharma GMP, strong audit experience, and the ability to lead cross-functional initiatives. Eligible for annual bonus; benefits on day one.