Quality Engineer

Job Summary

Under broad supervision, responsible for independently managing post-market quality activities to ensure compliance with applicable regulatory requirements and quality system standards. Conducts complaint investigations, evaluates post-market surveillance data, performs trend analysis, supports Medical Device Reporting (MDR) and Vigilance activities, and leads corrective and preventive action (CAPA) initiatives. Collaborates cross-functionally to identify quality risks, assess product performance in the field, and drive continuous improvement to maintain product safety and effectiveness.

Major 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.

Education

Typically requires a bachelor's degree in engineering, Science, Math or other related technical field.

Work Experience

• 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.
• Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook).
• Intermediate Skill Level in Microsoft Excel (for example: conditional formatting, tables, formulas, charting)

Preferred Work Experience

• At least 2 years of experience in complaint handling, post-market surveillance, MDR/Vigilance reporting, CAPA management, risk management, field actions, or medical device quality systems.
• Experience working with FDA 21 CFR Part 803, Part 820/QMSR, ISO 13485, EU MDR post-market requirements, and complaint handling processes.
• Experience performing complaint investigations, trend analysis, and regulatory reporting within the medical device industry.