Quality Assurance Scientist

Complaint Handling Quality Assurance Scientist 1 The Complaint Quality Assurance Scientist I (CHU) position within the Global complaint handling team provides a critical contribution to the overall quality and regulatory compliance of customer complaint investigation. More specifically, they will review, evaluate, and record activities and findings as part of an ongoing global quality process. This position will follow established procedures to: Enter and submit complaints on behalf of field-based personnel. Ensure supporting documentation is attached to complaints. Ensure complaints are correctly classified 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 the following documents as required: Risk assessments Stop ship assessments CAPA requests Represent QA on development, current business, or product improvement projects. Exercise judgment within defined procedures and practices to determine appropriate action. Direct communication and collaboration with other functions such as Field Service, Call Center, manufacturing, R&D, and other Post Market Surveillance teams will be fundamental to the success of this role. The ability to follow up effectively will be necessary. Data analysis and problem-solving skills are necessary to identify and countermeasure common failure issues. Robust documentation and strict adherence to approved procedures are a requirement in the highly regulated work environment. Gain and utilize basic product technical awareness to facilitate informed evaluation of customer complaints records being reviewed. Complete all needed records in a timely and accurate manner within Smart Solve (compliant management system (CMS)). Knowledge/Educational Requirements: Degree level in a Science or Engineering related discipline. 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. Good troubleshooting skills. #J-18808-Ljbffr TechDigital Group