Global Complaint QA Specialist

Job Title: Global Complaint QA Specialist
Location: Ewing, New Jersey
Type: Contract
Compensation: $35-$40/hr
Work Model: Remote

Overview

Responsibilities

• Coordinate complaint follow-ups with vigilance and global contact center partners to ensure all available information is obtained from complainants.
• Perform weekly complaint/event data reconciliation activities to mitigate the risk of reportable events not being reviewed in accordance with regulatory timelines.
• Responsible for submitting medical device near-incident reports to the applicable health authorities in accordance with regulatory timelines.
• Ensure documentation of reportability decisions is accurately noted within the complaint file.
• Perform assigned data quality tasks to ensure data integrity of complaint and vigilance files.
• Report key metrics from the global vigilance process to Vigilance and QA Team leadership to measure and control process performance.
• Support Vigilance team leadership with project or ad-hoc activities as required.

• Bachelor’s degree from an accredited institution (Science, Bio-medical preferred)
• 5+ years of experience with complaint handling processes preferred
• Ability to complete daily/monthly tasks to ensure timely delivery of outputs
• Ability to follow SOPs, WIs, or decision trees
• Ability to deliver required regulatory outputs in a prioritized manner
• Ability to balance multiple priorities to meet complaint handling system requirements

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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