Job Summary
A company is looking for a Complaint Investigator.
Key Responsibilities
- Review service records to identify product issues related to medical device/IVD quality complaints
- Document findings for each complaint investigation, including reportability assessment and corrective actions
- Collaborate with cross-functional teams to address product safety and quality issues
Required Qualifications
- Bachelor's degree in Biological Sciences or related field preferred
- Minimum 3+ years of experience in quality systems for medical devices or product investigations
- Experience with SAP and proficiency in Microsoft Office Products preferred
- Familiarity with ISO 13485 and 21 CFR quality management system requirements preferred
- Flexibility and a positive outlook toward handling new processes and technology
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