Post-Market Quality Engineer- Essential Wound Care

The Post-Market Quality Engineer is responsible for monitoring product performance in the field, overseeing complaint trends, and assisting with escalated investigations when necessary. This role ensures compliance with global regulatory requirements and drives continuous improvement through data analysis, risk-based testing, and collaboration with cross-functional teams to maintain product safety and effectiveness. 

Key Responsibilities 

• Lead post-market surveillance and trending by analyzing complaint data, defective products, and field performance metrics to identify trends, generate quarterly and annual reports, and implement corrective actions using statistical methods. 

• Conduct root cause analysis for escalated complaints, develop and execute test plans, and coordinate risk-based product testing with internal and external laboratories, including competitor product analysis as needed. 

• Maintain compliance with FDA 21 CFR 820, ISO 13485, EU MDR, and other global regulations for post-market activities, including health hazard evaluations, recalls, adverse event reporting, and change controls, while supporting audit readiness and regulatory inspections. 

• Lead investigations of non-conformances, implement effective corrective and preventive actions (CAPA), and collaborate with suppliers on SCARs, qualification requirements, and quality improvement initiatives. 

• Contribute to the maintenance of the Quality Management System (QMS) through internal audits and management reviews, and track and report post-market KPIs to ensure proactive risk management and continuous improvement. 

Education & Experience 

• Bachelor’s degree in Engineering, Science, or related technical field. 

• 2+ years of experience in Quality or Engineering; medical device industry experience preferred. 

Skills & Qualifications 

• Strong knowledge of post-market surveillance, complaint handling, and risk management (ISO 14971). 

• Working knowledge of government and industry quality assurance codes and standards (e.g. 21 CFR 820, ISO13485). 

• Proficiency in statistical analysis tools and MS Office Suite. 

• Experience with QMS software and complaint handling systems  

• Excellent problem-solving, communication, and cross-functional collaboration skills. 

• Ability to manage multiple projects and meet deadlines with minimal supervision. 

• Up to 15% travel required. 

Preferred Qualifications 

• 2+ years of industry experience in Medical Devices, Drugs, and/or fields directly related to the role. 

• Hands-on experience with post-market surveillance activities, including complaint trending, root cause investigations, and risk-based decision making for corrective actions.