Sandy, Utah
Quality System Specialist I(Medical Device Reports MDRs) Job Opening in Sandy, Utah - Qualifications: Preferred Bachelor?s degree in Health, Physical or Life Sciences, however associates degree with applicable experience will be considered. The manager would prefer someone with a Medical Lab Technician or Medical Technologist background. Under the direction of the Sr. Manager Quality Assurance the Staff Quality System Specialist will be responsible for processing of customer complaints specifically Medical Device Reports (MDR?s) and Adverse Drug Events (ADE's), including maintenance of complaint files, responses to customers and complaint reports. Training will be provided regarding processing of MDR?s and ADE's. Any students at the collegiate level nearing completion of a BS in Medical Laboratory Science, Biotechnology, Microbiology and Chemistry will be considered. Experience with technical writing is a plus. Responsibilities: Responsibilities: Under the direction of the Sr. Manager Quality Assurance the Staff Quality System Specialist II will be responsible for processing of customer complaints specifically Medical Device Reports (MDR?s) and Adverse Drug Events (ADE's), including maintenance of complaint files, responses to customers and complaint reports. Provide guidance and education regarding processing of MDR?s and ADE's. 1. Develop, implement and follow procedures to ensure timely and accurate writing of medical Device Reports related to customer complaints. 2. Maintain systems to monitor and facilitate the timely submittal of MDR reports. 3. Interact with Health Care Workers, Consumers and other professionals regarding their Product Complaints as needed. 4. Exhibit flexibility and adaptability by managing assignments in accordance with project priorities and by altering course of action when and where necessary. 5. Ensure ethical responsibility to maintain privacy and confidentiality of patient records and private information. 6. Complies with all local BD quality through consistent application of sound Quality Assurance principles. 7. Other duties as assigned.
Job Type: Contract
Required education:
Associate
Required experience:
Quality System: 1 year
medical and healthcare: 1 year
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