Post-Market Quality Engineer: CAPA & Compliance

Medline Industries, Inc.; Mundelein (IL); Sur place; USD 79 000 - 119 000; Plein temps

Avantages offerts par ce poste

Health insurance

401(k) contributions

Paid time off

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Quality system knowledge

Regulatory compliance mindset

Data analysis

Problem solving

Time management

Formation

Bachelor's degree in engineering or sciences

Outils

MS Office Suite

Microsoft Excel

Description du poste

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