Overview
Quality Complaints Analyst Jobs in New York, United States at Intellectt Inc
Title: Quality Complaints Analyst
Company: Intellectt Inc
Location: New York, United States
Job Title: Quality Complaints Analyst
Location: New York
Duration: 12 Months
Job Summary:
We are seeking a Quality Complaints Analyst with experience in the medical device industry to support complaint handling, investigations, and post-market quality activities. The candidate will evaluate customer complaints, perform root cause investigations, support CAPA activities, and ensure compliance with FDA and ISO 13485 requirements.
Key Responsibilities:
- Review and investigate product complaints in accordance with quality system procedures.
- Conduct root cause analysis using tools such as 5 Why, Fishbone, and 8D methodologies.
- Support CAPA, Non-Conformance, and Change Control activities.
- Perform complaint trending and data analysis to identify recurring quality issues.
- Collaborate with QA, Regulatory Affairs, Manufacturing, and Engineering teams.
- Maintain complaint records within eQMS and ensure timely closure.
- Support FDA inspections, internal audits, and regulatory compliance activities.
Requirements:
- Bachelor's degree in Engineering, Life Sciences, Biology, or related field.
- 3+ years of complaint handling, quality assurance, or quality engineering experience in the medical device industry.
- Knowledge of FDA 21 CFR Part 820, ISO 13485, CAPA, and complaint investigations.
- Strong analytical, documentation, and communication skills.
- Experience with TrackWise, MasterControl, SAP, or similar quality systems is preferred.
