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Quality Assurance Specialist - Doral, United States - Net2source
Description
Job Title:
Complaint Quality Assurance ScientistPlease read the information in this job post thoroughly to understand exactly what is expected of potential candidates
Location:
Miami FL % RemoteDuration: 06 Months ContractPayrate: $24.67/hr on W2 without benefitsShift: 8:00am to 5:00pmDescription: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 toEnter and submit complaints on behalf of field-based personnel
Complete the following documents as required:
o Risk assessmentso Stop ship assessmentso CAPA requestsRepresent QA on development, current business or product improvement projects.
Exercises 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.
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)).. Complete all needed records in a timely andaccurate manner.Knowledge/Educational Requirements:
Degree level in a Science or Engineering related discipline2 years' experience in a laboratory environment or Quality role with previous experience in aCHU environmentGood knowledge of FDA QSR and IS013485 requirementsGood Troubleshooting skills.