Quality Assurance Analyst ; Quality Reviewer

Quality Assurance Analyst I (Quality Reviewer)

We are seeking a Quality Assurance Analyst I (Quality Reviewer) to support complaint handling activities within a regulated life sciences environment and requires hands‑on experience reviewing complaint records to ensure accuracy, completeness, and compliance with applicable regulatory and quality system requirements.

• Review and assess the accuracy, completeness, and compliance of complaint records (including parent and child records) in accordance with internal procedures and regulatory requirements such as FDA 21 CFR Part 820, ISO 13485, and MDR.
• Provide clear, actionable quality feedback to complaint owners and investigators to ensure high‑quality documentation and adherence to quality system standards.
• Verify that all complaint files undergo Internal Quality Review and are completed, approved, and closed within defined timelines.
• Confirm that investigation records clearly document root cause analysis, corrective actions, and justification for closure.
• Facilitate meetings with stakeholders as needed to clarify complaint details, investigation expectations, and closure requirements.
• Ensure complaint files are audit‑ready and capable of standing alone during internal, external, or regulatory audits.
• Identify trends, process gaps, and recurring issues, and collaborate with cross‑functional teams to drive continuous improvement in complaint handling processes.

• Minimum 2+ years of experience in complaint handling or complaint review within medical device or pharmaceutical industries.
• Experience working in a regulated industry with exposure to quality systems and compliance requirements.
• Working knowledge of FDA 21 CFR Part 820, ISO 13485, and/or MDR.
• Strong experience reviewing and approving quality documentation.
• Familiarity with internal quality review and complaint closure processes.

Mid‑Senior level

Contract

Quality Assurance and Writing/Editing

Medical Equipment Manufacturing and Biotechnology Research