What are the responsibilities and job description for the Quality Complaints Investigator position at United Pharma?
Hiring Now – Quality Complaints Investigator
📍 Location: Irvine, CA
📅 Contract Duration: 12 Months Possible Extension
We are currently seeking an experienced Quality Complaints Investigator to support complaint handling and product quality investigations within a regulated medical device manufacturing environment. The ideal candidate will have strong analytical skills and hands-on experience managing complaint investigations, CAPA activities, and regulatory documentation.
Key Responsibilities:
- Perform detailed investigations for product complaints and non-conformance issues
- Review complaint records and identify root causes and corrective actions
- Collaborate with Manufacturing, Quality, Engineering, and Regulatory teams
- Support CAPA activities and maintain investigation documentation
- Analyze trends and support continuous quality improvement initiatives
- Ensure compliance with FDA, GMP, ISO 13485, and internal quality standards
- Assist during audits and regulatory inspections when needed
Qualifications:
- Bachelor’s degree in Life Sciences, Engineering, or related field
- 3 years of experience in complaint investigations or quality assurance
- Experience within medical device, pharma, or biotech industries preferred
- Knowledge of CAPA, NCR, and quality systems processes
- Strong documentation and communication skills
- Ability to work in fast-paced regulated environments