Job Summary
Job Description
The Post-Market Quality Engineer is responsible for monitoring product performance in the field, overseeing complaint trends, and assisting with escalated investigations when necessary. This role ensures compliance with global regulatory requirements and drives continuous improvement through data analysis, risk-based testing, and collaboration with cross-functional teams to maintain product safety and effectiveness.
Leadpost-marketsurveillanceandtrendingbyanalyzing complaint data, defective products, and field performance metrics to identify trends, generate quarterly and annual reports, and implement corrective actions using statistical methods.
Conduct root cause analysis for escalated complaints, develop and execute test plans, and coordinate risk-based product testing with internal and external laboratories, including competitor product analysis as needed.
Maintain compliance with FDA 21 CFR 820, ISO 13485, EU MDR, and other global regulations for post-market activities, including health hazard evaluations, recalls, adverse event reporting, and change controls, while supporting audit readiness and regulatory inspections.
Lead investigations of non-conformances, implement effective corrective and preventive actions (CAPA), and collaborate with suppliers on SCARs, qualification requirements, and quality improvement initiatives.
Hands-on experience with post-market surveillance activities, including complaint trending, root cause investigations, and risk-based decision making for corrective actions.
The anticipated salary range for this position:
$79,000.00 - $119,000.00 Annual
The actual salary will vary based on applicants 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 .
Were 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.
