Sr. Engineer, Quality Complaint Management
Axogen · Alachua, Florida, United States; Tampa, Florida, United States; WFH/Remote
Posted 22 days ago
or apply directly on Axogen's site. We never take the application ourselves.
Is this posting real?
- This role has been open
- 22 days Axogen's roles stay open a median of 22 days
- Reposted
- No
- Salary listed
- No 12% of Axogen's roles list one
- Ghost-job risk at Axogen
- high 15 stale, 1 reposted of 41 open
- Hiring momentum
- 65 roles opened in the last 90 days ↑ up vs. the prior 90 days
- Last confirmed on the employer's board
- 2026-09-17
Measured from postings appearing on and disappearing from Axogen's own greenhouse board since 2026-08-03. Full hiring picture for Axogen.
About this role
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
- 5/5
- freshness
- 4/5
- career value
- 4/5
- role clarity
- 4/5
- pay transparency
- 0/5
Scored from the posting itself — how clearly the role is described, how much it says about pay and benefits, and how recently it was listed. Not a judgement of Axogen as an employer.
What you need
- 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 you get
- Health, Dental, Vision
- Matching 401K
- Paid Time Off
- 9 Paid Holidays + 3 Floating Holidays
- Dependent Care Flexible Spending Accounts
- Medical Flexible Spending Accounts
Worth weighing
- Remote work option available
- Salary range provided is $84,190 — $105,237 USD
- Comprehensive benefits effective on date of hire
Summarised from Axogen's posting. Read the full original.
Listed by Axogen on their greenhouse job board, last confirmed open on 2026-09-17. PitchMeAI is not the employer.
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