Quality Technician (Complaint Remediation)
Job Summary
The Complaint Remediation Quality Tech is responsible for executing targeted product complaint remediation activities for Medline. This role focuses on retrospective complaint investigations, documentation updates, and cross-functional collaboration to ensure compliance with internal standards and external regulatory expectations.
Major Responsibilities
- Review and remediate historical product complaints to ensure completeness, accuracy, and compliance with updated regulatory and internal standards.
- Conduct retrospective investigations utilizing available data sources such as historical records, sample evaluations, image reviews, and trend analyses.
- Analyze updated investigation findings to ensure accurate root cause and draft clear, concise complaint updates based on results.
- Prepare and revise complaint records, including analysis summaries, closure statements, and remediation justifications.
- Apply updated procedural guidelines to identify complaints requiring escalation, including initiation of Corrective and Preventive Actions (CAPA), Supplier Corrective Action Requests (SCAR), or Health Hazard Evaluations (HHE), based on trend analysis and reclassification outcomes.
Education
High School Diploma/Equivalent with 3+ year of experience in Quality within the Medical Device or Pharma Industry OR Bachelor's degree in a relevant field with demonstrated experience handling product complaints in a regulated professional environment.
Knowledge / Skills / Abilities
- Strong cross-functional collaboration skills and ability to manage multiple tasks under critical deadlines.
- Strong analytical, critical thinking and problem-solving abilities with attention to detail.
- Basic proficiency with Microsoft Office Suite (Word, Excel, PowerPoint).
Preferred Job Requirements
- 2+ years of experience with product complaint remediation efforts in a regulated industry.
- Experience supporting efforts associated with or responding to FDA/ISO findings.
- Experience with SAP or similar complaint investigation software.
Pay
The anticipated salary range for this position is $23.25 - $33.75 hourly. The actual salary will vary based on applicant's location, education, experience, skills, and abilities. 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 as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.