Quality Control Technician[MDR reporting]

Description

• Duration 6 months - could be extended to 12 months.
• Hours are 8-5 target start 1st week of October, 10/1.
• Follow procedures to ensure timely and accurate receipt, logging, analysis and response to customer complaints relative to MDR reporting.
• Complete final review and approval of generated MDR reports in accordance with Client procedures and FDA regulations.
• Contribute to the business-wide quality strategy and quality objectives.
• Maintain systems to monitor and facilitate the timely MDR submittals.
• Monitor and communicate significant complaint trends, adverse events and other pertinent reports/ information relative to a specific MDR.
• Provide internal awareness of noted trends and complaint issues via periodic and ad hoc reports as required by the business unit/platform team.
• Interact with Health Care Workers, Consumers and other professionals regarding questions surrounding complaints.
• Exhibit flexibility and adaptability by managing assignments in accordance with project priorities and by altering course of action when and where necessary.
• Ensure ethical responsibility to maintain privacy and confidentiality of patient records and private information.
• Complies with all local Client quality policies/procedures/practices through consistent application of sound Quality Assurance principles.

Qualifications

• Must have a minimum of an associate’s degree. Education preferred in a science or engineering related discipline.