Quality Engineer

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

Responsible for executing targeted product complaint remediation activities. This role focuses on retrospective complaint investigations, documentation updates, and cross-functional collaboration to ensure compliance with internal standards and external regulatory expectations.

• 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.

degree in a relevant field with demonstrated experience handling product complaints in a regulated professional environment.

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)

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