Quality Complaint Management Engineer

Job Summary

Managing the complaint system, the full-time Sr. Engineer, Quality Complaint Management will serve as the principal investigator for tissue and biologics complaints, support Quality Engineering investigations, and ensure compliance with regulatory reporting requirements, with options for remote work.

Key responsibilities

• Lead investigations on tissue and biologics complaints and support Quality Engineering in medical device complaint investigations
• Draft and submit Health Hazard Evaluation Assessments, Field Alert Reports, and Medical Device Reports for regulatory review
• Monitor and report on the performance of the complaint management system, ensuring timely resolution and compliance

Required qualifications

• Bachelor's degree in a scientific or medical discipline
• At least five years of experience in the pharmaceutical or medical device industry, with a minimum of one year in complaint management
• Experience managing a complaint system compliant with 21 CFR and international standards
• Ability to assess and apply risk management principles per ISO 14971 and ICH Q9
• Strong independent decision-making skills and initiative