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Engineer II, Quality Complaint Management

Axogen
Location
Alachua, Florida, United States; Tampa, Florida, United States; WFH/Remote
Posted
23 days ago
Department
Quality
What they actually want (must-haves)
  • Bachelor’s degree in a scientific or medical discipline
  • At least 2 years’ experience in the pharmaceutical or medical device industry
  • Minimum of one year of experience working with medical device and/or pharmaceutical complaints
  • Ability to assess and apply risk management principles per ISO 14971 and ICH Q9
  • Strong oral and written communication, collaboration, and interpersonal skills
  • Well-organized with the ability to manage multiple priorities
Nice to have
  • Working experience managing a complaint system compliant with 21 CFR 211, 600, 820, 1271 and international standards
What the job really is

The Engineer II, Quality Complaint Management at Axogen is responsible for managing the complaint system, serving as the principal investigator for complaints, and ensuring compliance with regulatory standards. Daily tasks include drafting reports for regulatory bodies, coordinating with various departments on complaint assessments, and training personnel on the complaint system.

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
  • Salary range provided is $69,333 — $86,666 USD
  • Remote work option available
  • Role involves significant regulatory interaction and compliance responsibilities
Job score3.4/5
Benefits5/5
Freshness4/5
Career value4/5
Role clarity4/5
Pay transparency0/5

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