Quality Assurance Analyst I - Complaint Documentation Lead

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

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.