Quality Assurance Analyst

Job Description

Duties and Responsibilities:

• Review and assess the accuracy, completeness, and compliance of all complaint records (including parent and child records) in accordance with internal procedures and regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, 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 accurately document the root cause analysis, corrective actions, and justification for closure.
• Facilitate stakeholder meetings when necessary to clarify complaint details, investigation expectations, or 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 and closure processes.

Experience:

• 2+ years experience with complaints in med device, pharma background.
• Regulated industry experience.
• Experience in identifying and implementing continuous improvement initiatives within a regulated quality system environment.

Skills and Abilities:

• Strong analytical skills with attention to detail and accuracy in documentation review.
• Excellent written and verbal communication skills for effective collaboration with global and cross-functional teams.
• Demonstrated ability to coach, mentor, and train team members to improve complaint quality and compliance.
• Proven ability to organize, prioritize, and manage multiple complaint records to meet closure timelines.