Quality Engineer

Medline; Mundelein (IL); Vor Ort; USD 79.000 - 119.000; Vollzeit

Benefits dieser Stelle

Health insurance

401(k) contributions

Paid time off

Zusammenfassung

Medline Industries, LP is seeking a highly organized professional to manage post-market quality activities and ensure compliance with regulatory requirements and quality system standards in the United States. You will conduct complaint investigations, support MDR/Vigilance reporting, perform trend analyses, and lead CAPA initiatives to improve product safety and effectiveness.

Collaborating with Regulatory Affairs, Medical Affairs, Operations, and Product Management, you will review quality

Qualifikationen

• Bachelor’s degree in engineering, Science, Math or related technical field.
• 2+ years of experience in Quality or Engineering.
• Experience with post‑market surveillance, MDR/Vigilance reporting, CAPA management, risk management, field actions, or medical device quality systems is preferred.
• Experience with FDA 21 CFR Part 803, Part 820/QMSR, ISO 13485, EU MDR post‑market requirements, and complaint handling processes is a plus.

Aufgaben

• Manage post-market surveillance and complaint trending, adverse event monitoring, and analysis of product performance data to identify safety concerns.
• Conduct complaint investigations and evaluate issues for reportability, root cause, and CAPA.
• Analyze data to identify trends, assess risk, and support data-driven decisions; apply statistics.
• Lead investigations of nonconformances, complaints, adverse events, and field issues; develop and verify CAPAs.
• Collaborate with Regulatory Affairs, Medical Affairs, Operations, and Product Management on safety concerns and field actions.
• Review complaint records, investigation documentation, CAPAs, and quality records for FDA, ISO 13485, MDR compliance.
• Support management reviews with quality metrics, trend reports, and post-market surveillance summaries.
• Participate in internal and external audits and inspections related to complaint handling and CAPA processes.

Kenntnisse

Quality management

Data analysis

CAPA

Regulatory reporting

MDR reporting

Cross-functional collaboration

MS Office

Excel

Ausbildung

Bachelor's degree in engineering, Science, Math or related technical field

Tools

MS Office Suite

Excel

Jobbeschreibung

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.

Job Description

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.

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.

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. For a more comprehensive list of our benefits please click here.

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. Explore our Belonging page here.

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.