Sr. Engineer, Quality Control

Axogen is committed to building and maintaining a strong company culture that fosters professional growth and impacts patients' lives.
Vandalia, OH, USA
$79,356 - $99,195
Senior Software Engineer
Hybrid
5+ years of experience
Healthcare · Biotech

Description For Sr. Engineer, Quality Control

Axogen is seeking a Sr. Engineer, Quality Control to join their team. This role provides test method and qualification support, implements new processes, and drives continuous improvements in the Quality Control laboratory. The ideal candidate will have a Bachelor's degree in chemistry/biology or a related field, with 5+ years of experience in Quality Control, R&D Laboratory, or Quality Engineering, preferably in Biologics or Pharmaceuticals. Key responsibilities include driving OOS investigations, developing protocols for method improvements, managing commercial stability studies, and leading BLA support activities. The role requires expertise in quality control instrumentation, data analysis, and quality system regulations. Axogen offers a comprehensive benefits package, including health insurance, 401(k) matching, paid time off, and an employee stock purchase plan. The company culture values unique perspectives and is dedicated to impacting patients' lives positively. This position is based in Vandalia, OH, with a salary range of $79,356 - $99,195 USD. Axogen follows a hybrid work schedule for some positions, with 3 days in office and 2 days remote, though this may not apply to all locations.

Last updated 3 months ago

Responsibilities For Sr. Engineer, Quality Control

  • Drive completion of OOS investigations and deviations for QC
  • Develop protocols for method improvements
  • Partner with QC Lab Management on process improvements
  • Direct the completion of Qualification requirements for QC Lab Instrumentation
  • Manage Commercial stability studies
  • Lead and participate in BLA support activities
  • Define and implement automation and new capital projects
  • Provide statistical data support for Lean projects
  • Lead Quality Control issue resolution
  • Participate in FDA inspections and internal audits
  • Establish and track metrics for monitoring laboratory effectiveness

Requirements For Sr. Engineer, Quality Control

  • Bachelor's degree in chemistry/biology or related field
  • 5+ years' experience in Quality Control laboratory, R&D Laboratory, or Quality Engineering
  • Understanding of quality control instrumentation and testing methods
  • Problem solving using root cause methodologies
  • Applying statistics and software in data analysis
  • Knowledge of quality system regulations
  • Six Sigma Green/Black Belt preferred

Benefits For Sr. Engineer, Quality Control

Medical Insurance
Dental Insurance
Vision Insurance
401k
Parental Leave
Equity
  • Health Insurance
  • Dental Insurance
  • Vision Insurance
  • 401(k) retirement plan with matching
  • Paid Time Off
  • 9 Paid Holidays + 2 Floating Holidays
  • Dependent Care Flexible Spending Accounts
  • Medical Flexible Spending Accounts
  • Tuition Reimbursement
  • Paid Parental Leave
  • Paid Caregiver Leave
  • Basic Life Insurance
  • Supplemental Life Insurance
  • Employee Stock Purchase Plan
  • Disability Insurance
  • Annual bonus eligibility

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