Quality Assurance Analyst I (Quality Reviewer)

Intellectt Inc; New Jersey; On-site; USD 65,000 - 85,000; Part time

Job summary

A leading life sciences company in New Jersey seeks a Quality Assurance Analyst I to review complaint records and ensure compliance with regulatory quality standards. The role involves providing quality feedback, facilitating investigations, and ensuring files are audit-ready. Candidates should have over 2 years of experience in complaint handling within medical device or pharmaceutical industries, with strong knowledge of FDA regulations. This is a contract position offering vital support in maintaining quality standards.

Qualifications

• Minimum 2+ years of experience in complaint handling or complaint review.
• Experience in a regulated industry with exposure to quality systems.
• Working knowledge of FDA 21 CFR Part 820, ISO 13485, and/or MDR.

Responsibilities

• Review and assess the accuracy of complaint records.
• Provide actionable quality feedback to complaint owners.
• Ensure complaint files are audit-ready.

Skills

Complaint handling

Quality documentation review

Root cause analysis

Regulatory compliance

Continuous improvement

Job description

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.

Key Responsibilities

• 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.

Required Qualifications

• 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.

Seniority Level

Mid‑Senior level

Employment Type

Contract

Job Function

Quality Assurance and Writing/Editing

Industries

Medical Equipment Manufacturing and Biotechnology Research