Senior Specialist Quality Assurance

Required Qualifications

• Associate degree

• 2-4 years of experience in the relevant field - engineering and/or technical operational
• Advanced computer skills, including statistical/data analysis and report writing
• Strong communication, teamwork, and organizational skills
• Ability to work in a diverse environment

What You’ll Work On

• Responsible for scheduling day-to-day activities to ensure timely review of medical event files within established timeframes.
• Ensures potentially reportable complaints are assessed against criteria for reportability and reports are filed as necessary in compliance with worldwide regulations.
• Works closely with Medical Affairs, Technical Support, Complaint Handling, and Complaint Investigation teams to ensure that the appropriate information is obtained from complainants to make sure an accurate and timely assessment of reportability is made.
• Utilizes good judgment and makes timely decisions considering the facts and data at hand;; knows when to escalate to management.
• Coordinates changing priorities
• Uses tools effectively to monitor progress and results.
• Collaborates with international country offices providing data, answers to questions, information for other countries’ competent authorities, metrics, and process enhancements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, distributors, affiliates and authorized representatives.
• Performs verification of vigilance reports, as well as verification of data compiled for metrics.
• Manages the Reportable Confirmed Malfunction List (RCML) process by running monthly reports and reporting as necessary.
• Performs other related duties and responsibilities, on occasion, as assigned.