Product Quality Engineer

Spark Life Solutions Inc is a company focused on medical devices, and they are seeking a Post Market Quality Engineer to support post-market quality activities. This role involves monitoring complaint trends, leading investigations, and ensuring regulatory compliance with relevant standards.

Responsibilities:

• Perform complaint trend analysis and statistical review of product quality data
• Lead Post Market Surveillance Review Board (PMSRB) meetings and support PMS activities
• Prepare and maintain PMS documentation, including PMS Plans, PMS Reports, and PSURs
• Conduct Health Hazard Evaluations (HHE) and Health Risk Assessments (HRA) for field issues
• Lead complaint investigations and root cause analysis to determine corrective actions
• Collaborate with R&D, Manufacturing, and Quality teams to implement design or process improvements
• Present product quality metrics and investigation results to leadership
• Support internal and external audits, including FDA inspections
• Travel to customer sites as needed (up to 25%)

Requirements:

• Bachelor's degree in Engineering or related field
• 5+ years of experience in Post-Market Quality or Product Quality Engineering within the medical device industry
• Strong knowledge of FDA regulations, ISO 13485, ISO 14971, and EU MDR
• Experience with complaint investigations, risk assessments, and post-market surveillance activities