Product Quality Engineer

Remote, long-term contract role supporting quality engineering for electro-mechanical medical devices.

About the role

We are seeking an experienced Product Quality Engineer to support quality engineering activities for electro-mechanical medical devices involving both hardware and software. The ideal candidate will have strong experience investigating product failures, driving root cause analysis, and implementing corrective actions within a regulated medical device environment.

Responsibilities

• Investigate product failures and perform root cause analysis.
• Support CAPA, non-conformance, and complaint investigations.
• Collaborate with Design, Manufacturing, Software, Hardware, and Quality teams to resolve product issues.
• Analyze product performance data and recommend quality improvements.
• Ensure compliance with FDA, ISO 13485, and medical device quality standards.
• Support risk management and continuous improvement initiatives.

Requirements

• Bachelor's degree in Engineering or a related field.
• 5+ years of Product Quality Engineering experience in the medical device industry.
• Experience with electro-mechanical devices involving hardware and software.
• Strong knowledge of failure investigations, CAPA, root cause analysis, and risk management.
• Familiarity with FDA regulations and ISO 13485.