Quality Engineer

Job Description

Support remediation activities with a focus on retrospective complaint review reportability assessments under FDA requirements. 

Responsibilities

·         Review historical complaint files as part of a remediation or retrospective review effort to verify completeness and reassess MDR reportability decisions.

·         Apply current FDA MDR definitions, criteria, and decision trees to legacy complaints to determine whether an MDR should have been filed.

·         Identify missing or incomplete data within complaint records and work cross-functionally with Quality, Regulatory, Operations, and other teams to obtain necessary information for a defensible decision.

·         Prepare and submit MDRs through the FDA’s electronic MDR (eMDR) system when remediation identifies reportable events.

·         Support compliance with FDA Quality System Regulations, including complaint handling requirements under 21 CFR 820.198, within strict remediation timelines.

Essential Skills

·         Hands-on experience reviewing both historical and newly received product complaints for MDR reportability in compliance with FDA regulations (21 CFR Part 803).

·         Working knowledge of FDA MDR regulations (21 CFR 803) and complaint handling requirements.

·         Strong ability to interpret medical narratives, product information, and adverse event descriptions to assess severity, outcome, and reportability.

·         Experience managing high volume documentation reviews or participating in large-scale remediation or retrospective review projects.

·         Strong analytical skills and attention to detail.

·         Ability to work in a fast-paced environment.

Additional Skills & Qualifications

·         A Bachelor’s degree in a relevant field is preferred but not required.

·         At least 1+ year of experience in complaint handling, MDR evaluation, or similar regulated industry experience.

·         2+ years of MDR reporting or complaint remediation experience in a medical device or pharmaceutical environment is preferred.

·         Experience working in remediation environments with aggressive deadlines and throughput expectations.

·         Familiarity with complaint management systems such as SAP, TrackWise, or similar platforms.