Overview
Medical Device Complaint Investigator (DHR and Return Sample Review) Jobs in El Paso, TX at Rock Health
Title: Medical Device Complaint Investigator (DHR and Return Sample Review)
Company: Rock Health
Location: El Paso, TX
Medical Device Complaint Handling Investigator (DHR and Return Sample Review)
Role Overview: Provides support to the complaint management team by investigating, documenting, and resolving product complaints in compliance with regulatory and internal standards. Ensures complaint handling tasks are completed accurately and efficiently.
Key Responsibilities
- Receive, log, and process product complaints from various sources, ensuring data accuracy.
- Conduct thorough investigations, including reviewing records and collaborating with departments.
- Perform root cause analysis for complaint trends and significant issues.
- Document investigation activities, findings, and resolutions clearly within quality systems.
- Communicate with stakeholders and regulatory bodies as needed.
- Ensure compliance with FDA, ISO, and other regulatory guidelines.
- Identify and escalate safety or quality concerns to management.
- Participate in process improvement initiatives and report complaint metrics.
Qualifications & Skills
- Bachelor’s degree in a scientific, engineering, or related field preferred.
- At least 2 years of experience in a regulated industry with complaint handling, quality assurance, or regulatory roles.
- Strong knowledge of quality management systems (ISO 13485, 21 CFR Part 820) and medical device regulations.
- Excellent communication and analytical skills, with proficiency in root cause analysis.
- Attention to detail and ability to work independently or in a team.
- Proficiency in Microsoft Office; experience with quality management software is a plus.
