Product Quality Engineer

Job Overview

We are looking for a Product Quality Engineer to provide expert support in investigating complaints related to complex medical devices such as Defibrillators and Pacemakers. This position focuses on analyzing device failures through risk assessments, root cause identification, and comprehensive review of investigation findings. The role is assessment-driven and does not require hands-on repair of devices.

Key Responsibilities

• Conduct investigations into product complaints and device malfunctions.
• Perform detailed root cause, hazard, and risk analyses.
• Review and approve conclusions drawn from investigations.
• Analyze failures in hardware, software, and electrical components.
• Identify quality trends and contribute to product quality enhancement efforts.
• Ensure all documentation aligns with FDA regulations and quality system standards.

Required Qualifications

• Bachelor's degree in Electrical, Biomedical, Mechanical, or a related Engineering discipline.
• More than three years of experience in Product Quality Engineering or Investigations of Medical Device Complaints.
• Proficient in Device Failure Analysis, Hazard & Risk Analysis, and Root Cause Analysis methodologies.
• Strong understanding of electrical failures, PCBA, and hardware/software-based medical device technologies.
• Experience working within a FDA-regulated medical device industry environment.

Preferred Qualifications

• Degree specifically in Electrical Engineering.
• Experience with complex implantable devices such as Defibrillators or Pacemakers.
• Familiarity with complaint management, Corrective and Preventive Actions (CAPA), and post-market surveillance processes.