Quality Complaint Management Engineer

Job Summary

To manage the complaint system effectively, the full-time Quality Complaint Management Engineer will serve as the principal investigator for complaints, draft regulatory submissions, and drive performance metrics while working remotely or onsite in Alachua or Tampa.

Key responsibilities

• Support investigators on complaints for all product lines and draft Health Hazard Evaluation Assessments, Field Alert Reports, and Medical Device Reports
• Drive and report on the performance of the complaint management system, including complaint trending and regulatory reporting timeliness
• Coordinate timely Adverse Event determination and pharmacovigilance reporting while training personnel on the complaint system

Required qualifications

• Bachelor's degree in a scientific or medical discipline
• At least 2 years of experience in the pharmaceutical or medical device industry, including 1 year with medical device and/or pharmaceutical complaints
• Experience managing a complaint system compliant with 21 CFR 211, 600, 820, 1271, and international standards
• Ability to assess and apply risk management principles per ISO 14971 and ICH Q9
• Independent decision-making with high initiative