Quality Specialist

Complaint Remediation Quality Specialist Complaint handling / investigations experience – does not want candidates just doing complaint intake Gathering evidence Critical thinking Does not need MDR experience but that’s a plus No lab people (manager does not like candidates coming from a lab environment) Investigated samples Understand confirmed and not confirmed CAPA’s 5 why’s 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. MINIMUM JOB REQUIREMENTS 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. #J-18808-Ljbffr