Post-Market Quality Engineer — CAPA & MDR Expert

Medline; 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 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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality management

Data analysis

CAPA

Regulatory reporting

MDR reporting

Cross-functional collaboration

MS Office

Excel

Education

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

Tools

MS Office Suite

Excel

Job description

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