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← Axogen

Sr. Engineer, Supplier Quality

Axogen
Location
Vandalia, Ohio, United States
Posted
23 days ago
Department
Quality
What they actually want (must-haves)
  • Bachelor's degree in the sciences (biology, chemistry, biochemistry, or chemical engineering)
  • 5+ years of pharmaceutical or biopharmaceutical experience in a GMP environment
  • Minimum 2 years auditing experience in pharmaceutical or medical device industry
  • Experience managing a supplier quality management program
  • Demonstrated understanding of Quality principles, industry practices, and standards (21 CFR, ISO, GxP, ICH)
  • Experience with commercial drug product operations including biologics, finished goods production, API and excipient manufacturing, and analytical testing
Nice to have
  • Quality auditor certification
  • Combination product or medical device experience
What the job really is

The Sr. Engineer, Supplier Quality at Axogen is responsible for managing the Supplier Quality Management Program, ensuring compliance with regulatory requirements, and overseeing supplier audits. Daily tasks include leading audits, maintaining supplier agreements, collaborating with stakeholders, and supporting quality assurance processes related to contract service providers.

Benefits
  • Health, Dental, Vision
  • Matching 401K
  • Paid Time Off
  • 9 Paid Holidays + 3 Floating Holidays
  • Dependent Care Flexible Spending Accounts
  • Medical Flexible Spending Accounts
Things to weigh
  • No specific mention of remote work options
  • Salary range provided is relatively narrow
  • Focus on regulatory compliance may limit innovation opportunities
Job score3.6/5
Benefits5/5
Freshness4/5
Career value4/5
Role clarity5/5
Pay transparency0/5

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