Product Quality Engineer

Role : Product Quality Engineer – Complaint Investigations

Location : Remote

Durations : 12+months

Contract : W2

Our client is seeking an experienced Product Quality Engineer to support post-market complaint investigations for advanced cardiac rhythm management devices. This role is responsible for conducting engineering evaluations, analyzing product performance, investigating customer complaints, and performing risk assessments to ensure product quality, regulatory compliance, and patient safety.

Key Responsibilities

• Review investigation findings and perform comprehensive complaint assessments.
• Analyze product performance trends and post-market surveillance data to identify potential quality issues.
• Conduct device failure investigations and support root cause analysis.
• Participate in hazard analysis, risk assessments, and risk management activities.
• Collaborate with cross-functional teams, including Engineering, Quality, and Regulatory Affairs, to resolve product-related issues.
• Prepare detailed technical reports, investigation summaries, and quality documentation in accordance with regulatory requirements.

Required Qualifications

• Bachelor's degree in Engineering or a related technical discipline.
• Hands-on experience with medical device complaint investigations or product quality engineering.
• Strong background in device failure analysis, root cause investigation, and hazard/risk analysis.
• Experience supporting hardware- and/or software-based medical devices in a regulated environment.
• Excellent analytical, problem-solving, and technical documentation skills.
• Knowledge of FDA regulations, ISO 13485, and medical device quality systems is a plus.