Job Description

Job Title: Quality Assurance Analyst I

Location: Princeton, NJ

Work Mode: Hybrid

Duration: 6 Months

Job Summary:

The Quality Assurance Analyst I will serve as a Quality Reviewer, responsible for reviewing and approving complaint records to ensure accuracy, completeness, and compliance with internal procedures and applicable regulatory requirements. This role supports complaint handling processes within a regulated medical device and/or pharmaceutical environment and collaborates closely with cross-functional teams to ensure audit-ready documentation and timely complaint closure.

Key Responsibilities:

• Review and assess complaint records (including parent and child records) for accuracy, completeness, and compliance with internal procedures and regulatory requirements, including 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.
• Ensure all complaint files undergo internal quality review and are completed, approved, and closed within defined timelines.
• Verify that investigation records accurately document root cause analysis, corrective actions, and appropriate justification for complaint closure.
• Facilitate meetings with stakeholders as needed to clarify complaint details, investigation expectations, and closure requirements.
• Ensure complaint files are audit-ready and can stand alone during internal, external, or regulatory audits.
• Identify trends, recurring issues, and process gaps in complaint handling, and collaborate with cross-functional teams to drive continuous improvement initiatives.

Required Experience & Qualifications:

• Minimum of 2+ years of experience reviewing or handling complaints in a regulated environment.
• Experience in the medical device industry preferred; pharmaceutical or other regulated industry experience may be considered.
• Working knowledge of complaint handling regulations and standards, including FDA 21 CFR Part 820 and ISO 13485 (MDR experience is a plus).
• Strong analytical skills with exceptional attention to detail and accuracy in documentation review.
• Excellent written and verbal communication skills, with the ability to collaborate effectively with cross-functional and global teams.
• Proven ability to manage multiple complaint records simultaneously and meet closure timelines.
• Demonstrated experience in coaching, mentoring, or training team members to improve complaint quality and compliance.
• Experience identifying opportunities for continuous improvement within a regulated quality system environment.

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