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Job Summary:
The Complaint Quality Assurance Scientist I (CHU) play a pivotal role in ensuring the overall quality and regulatory compliance of customer complaint investigation processes. This position involves reviewing, evaluating, and documenting activities and findings as part of our ongoing global quality process. The incumbent will follow established procedures to enter and submit complaints, ensure supporting documentation is attached, correctly classify complaints, and assign investigators/reviewers. Additionally, they will design and perform complaint investigations, conduct reviews of complaint trending, and escalate product issues to management. The CHU will complete various documents as required, represent QA on cross-functional projects, and exercise judgment within defined procedures and practices.
Key Responsibilities:
Enter and submit complaints on behalf of field-based personnel
Ensure supporting documentation is attached to complaints
Correctly classify complaints and assign investigators/reviewers
Design and perform complaint investigations into the Chemistry/Immunoassay product line
Conduct reviews of complaint trending to determine CAPA eligibility
Escalate product issues to management
Complete risk assessments, stop ship assessments, and CAPA requests
Represent QA on development, current business, or product improvement projects
Communicate and collaborate with other functions such as Field Service, Call center, manufacturing, R&D, and Post Market Surveillance teams
Utilize data analysis and problem-solving skills to identify and countermeasure common failure issues
Maintain robust documentation and adhere strictly to approved procedures
Gain and utilize basic product technical awareness to facilitate informed evaluation of customer complaints records
Complete all needed records in a timely and accurate manner within Smart Solve (compliant management system (CMS
Qualifications:
Bachelor's degree in a Science or Engineering related discipline
Minimum 2 years' experience in a laboratory environment or Quality role with previous experience in a CHU environment
Good knowledge of FDA QSR and ISO 13485 requirements
Strong troubleshooting skills
Date Posted: 20 May 2024
Job Expired - Click here to search for similar jobs