Quality Engineer

About This Role

This Quality Engineer role involves independently managing post-market quality activities to ensure compliance with regulatory requirements and quality system standards. The position focuses on conducting complaint investigations, evaluating post-market surveillance data, and leading corrective and preventive action initiatives. It suits a professional dedicated to identifying quality risks and driving continuous improvement for product safety and effectiveness.

Responsibilities

• Manage and execute post-market surveillance activities, including complaint trending, adverse event monitoring, and analysis of product performance data to identify emerging quality and safety concerns
• Conduct complaint investigations and evaluate product-related issues to determine reportability, root cause, and appropriate corrective actions
• Support regulatory reporting requirements, including Medical Device Reports (MDRs), Vigilance Reports, and other global post-market submissions
• Analyze complaint, audit, service, and field performance data to identify trends, assess risk, and recommend quality improvements
• Apply statistical techniques to support data-driven decision making
• Lead and support investigations of nonconformances, complaints, adverse events, and field issues
• Develop, implement, and verify corrective and preventive actions (CAPA) to address identified risks and systemic issues
• Partner with Regulatory Affairs, Medical Affairs, Operations, and Product Management to assess product safety concerns and support field actions, recalls, health hazard evaluations, and regulatory inquiries as required
• Review and evaluate complaint records, investigation documentation, CAPAs, and quality records to ensure compliance with FDA, ISO 13485, MDR, and other applicable regulatory requirements
• Support management review activities through preparation of quality metrics, trend reports, post-market surveillance summaries, and effectiveness monitoring of quality system processes
• Participate in internal and external audits and support inspections related to complaint handling, post-market surveillance, MDR reporting, and CAPA processes

Requirements

• Bachelor’s degree in engineering, Science, Math or other related technical field
• At least 2 years of experience in Quality or Engineering
• Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives, and determining when escalation of issues is necessary
• Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects
• Experience problem solving, overcoming obstacles, and reaching a positive and successful solution through mathematical or systematic operations