Overview
Complaints Investigator – Medical Device Jobs in New York, United States at Intellectt Inc
Title: Complaints Investigator – Medical Device
Company: Intellectt Inc
Location: New York, United States
Job Title: Complaints Investigator – Medical Device
Location: Tonawanda, NY (Onsite)
Duration: 12 Months
Position Overview:
We are seeking an experienced Complaints Investigator to support a leading medical device manufacturer by conducting end-to-end investigations of product complaints related to women's health medical devices. The successful candidate will work onsite as part of a collaborative quality team and report directly to the Quality Manager.
Key Responsibilities:
- Conduct end-to-end complaint investigations for medical device products.
- Review, analyze, and document complaint records in compliance with regulatory and quality requirements.
- Perform product evaluations and functional testing as part of investigation activities.
- Identify root causes and support remediation efforts for complaint-related issues.
- Manage a high-volume workload of approximately 30+ complaint investigations per day.
- Utilize QMS platforms to document investigations, findings, and corrective actions.
- Ensure investigations are completed accurately and within established timelines.
- Collaborate with Quality, Manufacturing, Engineering, and Regulatory teams as needed.
- Maintain compliance with FDA, GMP, and company quality system requirements.
Required Qualifications:
- Bachelor's degree in Science, Engineering, or a related technical field.
- 5+ years of complaint investigation experience within the United States.
- Experience in Medical Device or Pharmaceutical industries.
- Proven experience handling high-volume complaint investigations (30+ cases per day).
- Strong understanding of Quality Management Systems (QMS).
- Experience conducting remediation-related complaint investigations.
- Ability to work independently with minimal supervision.
- Excellent analytical, problem-solving, and technical writing skills.
Preferred Qualifications:
- Hands-on experience with TrackWise.
- Experience working in FDA-regulated manufacturing environments.
- Knowledge of CAPA, root cause analysis, and quality investigations.
