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Manager, Quality Assurance

Axogen
Location
Vandalia, Ohio, United States
Posted
18 days ago
Department
Quality
What they actually want (must-haves)
  • Bachelor’s Degree in Life Science or Engineering discipline and/or a related field
  • Minimum of 5 years Quality Engineering/Quality Assurance experience in medical device, pharmaceutical, or biotech manufacturing
  • Minimum 3 years of leading others or project management, direct people management preferred
  • Experience leading external regulatory audits (e.g., FDA, ISO)
  • Knowledge of current Good Manufacturing Practices (cGMP) and relevant regulatory standards
  • Knowledge of statistical sampling and analysis
Nice to have
  • Proficiency in Six Sigma or Lean Manufacturing is desirable
  • Certified Quality Engineer preferred
What the job really is

The Manager, Quality Assurance at Axogen is responsible for overseeing and maintaining Quality Assurance processes in compliance with relevant manufacturing practices and standards for medical devices and biologics. This role involves managing quality departments, collaborating with operations to ensure compliance, and implementing quality strategies that align with company goals. The manager will also lead a team, conduct audits, and support continuous improvement initiatives across various operational functions.

Benefits
  • 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
  • Employee Stock Purchase Plan
  • Referral incentive program
Things to weigh
  • Salary range is specified, which may help in negotiations.
  • Travel requirements are up to 10%, which could impact work-life balance.
  • The role involves significant regulatory compliance responsibilities, which can be demanding.
  • The position requires leading a team, which may involve challenges in team dynamics and management.
Job score3.4/5
Benefits4/5
Freshness4/5
Career value4/5
Role clarity5/5
Pay transparency0/5

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