Medical Device Complaints Engineers and Technicians

Overview

ELIQUENT Life Sciences is hiring 50 Complaints Engineers and 50 Complaint Technicians for full-time, remote roles starting in the next 2-3 weeks. If you are interested, please email [email protected].

Role Description

This full-time, remote role focuses on investigating and resolving product complaints for medical devices. Responsibilities include receiving and documenting complaints, reviewing device performance data, and coordinating testing to assess product functionality and safety. Team members will conduct failure analysis, collaborate with R&D and quality teams to identify root causes, and support implementation of corrective and preventive actions. The role involves preparing technical investigation reports, maintaining compliant documentation, and supporting regulatory submissions and audits.

Key Responsibilities for Complaint Technicians

• Maintain compliance with applicable quality requirements.
• Receive and verify returned product complaints; perform initial investigation and root-cause testing; and enter accurate information into the GCMS database.
• Ensure product traceability for all products received and analyzed.
• Partner with cross-functional groups (e.g., R&D and Manufacturing) to obtain information needed to complete investigations.
• Follow up with CMC to confirm reported coding is accurate.
• Prepare and route complaints for approval.
• Assist in maintaining and updating returned-product test procedures.
• Identify opportunities and recommend improvements to complaint-handling processes.
• Maintain lab cleanliness and operate in compliance with corporate procedures.

Qualifications

• Strong foundation in Physics and Device Physics.
• Experience in Research and Development (R&D), including experimental design and data interpretation.
• Hands-on skills in Testing and Failure Analysis for medical devices.
• Knowledge of medical device regulations and standards (e.g., ISO 13485, 21 CFR Part 820).
• Prior experience in medical device complaint handling, quality engineering, or reliability engineering is preferred.
• Strong analytical, problem-solving, and technical writing skills.
• Ability to work independently in a remote environment and manage multiple investigations simultaneously.

Company Description

ELIQUENT Life Sciences is a global regulatory consulting firm supporting life sciences innovators in gaining and maintaining market authorization. We bring together regulatory leaders and technical specialists to provide integrated solutions across the therapeutic landscape.