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

Nice to have:

• 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

Benefits

• Competitive total rewards package
• Continuing education and training
• Bonus and/or incentive eligible
• Health insurance
• Life and disability
• 401(k) contributions
• Paid time off
• Access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp (for employees working less than 30 hours per week)

About the Company

Medline Industries, LP, and its subsidiaries, is a growing worldwide organization dedicated to creating a workplace where everyone feels they belong and can grow their career.