Quality Engineer

Medline Industries, Inc.; Mundelein (IL); On-site; USD 79,000 - 119,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a post-market quality professional to lead surveillance activities, investigations, CAPA programs, and regulatory reporting to ensure FDA, ISO 13485, and MDR compliance, and to maintain product safety and effectiveness.

You will collaborate with Regulatory Affairs, Medical Affairs, Operations, and Product Management to assess product safety concerns, support field actions and recalls, monitor performance data, and drive continuous improvement through

Qualifications

• Requires bachelor’s degree in engineering, science, math or related technical field.
• Experience with quality systems and regulatory requirements (FDA, ISO 13485, MDR) is preferred.
• Experience in post-market activities, complaint handling, CAPA, and data analysis is ideal.

Responsibilities

• Manage post-market surveillance activities including complaint trending and adverse event monitoring.
• Conduct complaint investigations to determine reportability, root cause and corrective actions including regulatory reporting.
• Analyze data to identify trends, assess risk, and recommend quality improvements using statistical methods.
• Lead investigations of nonconformances and CAPA to address risks and systemic issues.
• Collaborate with Regulatory Affairs, Medical Affairs, Operations and Product Management on field actions and regulatory inquiries.
• Review records and documentation to ensure compliance with FDA/ISO requirements and quality systems.
• Support management reviews with quality metrics and trend reports.
• Participate in audits and inspections related to post-market surveillance and CAPA processes.

Skills

Quality system knowledge

Regulatory compliance mindset

Data analysis

Problem solving

Time management

Education

Bachelor's degree in engineering or sciences

Tools

MS Office Suite

Microsoft Excel

Job description

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.

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

Salary

The anticipated salary range for this position:

$79,000.00 - $119,000.00 Annual

The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.

Benefits

• Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average.
• For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.