Quality Engineer

Medline • Mundelein, IL

23d

About The Position

Under broad supervision, the Quality Engineer independently manages post-market quality activities to ensure compliance with applicable regulatory requirements and quality system standards. The role 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. It collaborates cross-functionally to identify quality risks, assess product performance in the field, and drive continuous improvement to maintain product safety and effectiveness.

The position also supports regulatory reporting, audits, management review, field actions, recalls, health hazard evaluations, and regulatory inquiries. It reviews quality records for compliance with applicable FDA, ISO 13485, MDR, and other regulatory requirements.

Requirements

• Bachelor’s degree in engineering, science, math, or another related technical field.
• At least 2 years of experience in Quality or Engineering.
• Ability to develop ways of accomplishing goals with little or no supervision, depend on oneself to complete objectives, and determine when escalation of issues is necessary.
• Time management skills to prioritize, organize, and track details to meet deadlines across multiple projects.
• Problem-solving experience, including overcoming obstacles and reaching successful solutions through mathematical or systematic operations.
• Experience using Microsoft Office Suite products, including Word, Excel, PowerPoint, and Outlook.
• Intermediate Microsoft Excel skills, such as conditional formatting, tables, formulas, and charting.

Nice To Haves

• 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.

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 by preparing 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.

Benefits

• Competitive total rewards package.
• Continuing education and training.
• Bonus and/or incentive eligibility.
• Health insurance for eligible employees.
• Life and disability benefits for eligible employees.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level