What are the responsibilities and job description for the Complaints Assessor position at United Consulting Hub?
Job Title: Complaints Investigator
Location: NY
Employment Type: Contract (W2 Only)
Industry: Medical Devices
Job Summary
We are seeking a detail-oriented Entry-Level Complaints Investigator to support complaint handling and investigation activities for medical device products within a regulated quality environment.
The ideal candidate will assist with end-to-end complaint investigations, documentation review, functional testing, and quality system activities while working closely with Quality and Manufacturing teams.
This position requires strong analytical skills, attention to detail, and the ability to work in a fast-paced onsite manufacturing environment.
Key Responsibilities
- Support investigation of product complaints related to medical device products
- Perform documentation review, data analysis, and complaint trending activities
- Assist with product evaluations and functional testing activities
- Document investigation findings within the TrackWise QMS system
- Support root cause analysis and corrective action activities
- Collaborate with Quality, Manufacturing, and Engineering teams
- Ensure complaint records are accurate, complete, and compliant with FDA and quality requirements
- Support weekly productivity and investigation metrics
Required Qualifications
- Bachelor’s degree in Engineering, Life Sciences, Biology, Biomedical Engineering, or related field
- 0–2 years of experience in Quality, Complaint Handling, Manufacturing, or regulated industries
- Basic understanding of:
- FDA Regulations
- GMP/cGMP
- Quality Systems
- Medical Device Complaint Handling
- Strong analytical, organizational, and documentation skills
- Ability to work independently and in team environments
- Strong attention to detail and problem-solving skills
Preferred Skills
- Familiarity with TrackWise or other QMS systems
- Exposure to complaint investigations, CAPA, or root cause analysis
- Experience in medical device or regulated manufacturing environments
- Basic laboratory or functional testing experience is a plus
Experience Required
- Entry Level / 0–2 years of relevant experience in medical devices or regulated industries