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Sr. Engineer, Quality Complaint Management

Axogen
Location
Alachua, Florida, United States; Tampa, Florida, United States; WFH/Remote
Posted
26 days ago
Department
Quality
What they actually want (must-haves)
  • Bachelor’s degree in a scientific or medical discipline
  • At least five years’ experience in the pharmaceutical or medical device industry
  • Minimum of one year of experience working with medical device and/or pharmaceutical complaints
  • Working experience managing a complaint system compliant with 21 CFR 211, 600, 820, 1271 and international standards
  • Strong oral and written communication skills
  • Ability to assess and apply risk management principles per ISO 14971 and ICH Q9
Nice to have
  • Experience with Health Hazard Evaluation Assessments (HHEAs), Field Alert Reports (FARs), and Medical Device Reports (MDRs)
  • Experience supporting regulatory and notified body inspections
What the job really is

The Sr. Engineer, Quality Complaint Management at Axogen is responsible for managing the complaint system, serving as the principal investigator for complaints related to tissue and biologics, and ensuring compliance with regulatory standards. Daily tasks include drafting reports for regulatory bodies, monitoring complaint management performance, and coordinating with various departments to ensure timely complaint assessments and reporting.

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
  • Remote work option available
  • Salary range provided is $84,190 — $105,237 USD
  • Comprehensive benefits effective on date of hire
Job score3.4/5
Benefits5/5
Freshness4/5
Career value4/5
Role clarity4/5
Pay transparency0/5

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