Quality Assurance Analyst

Job TitleQuality Assurance Analyst

Job Description

In this role, you have the opportunity to:

Become trained and BIU qualified in HHM coding.

Acquire basic knowledge of products, tools and processes.

Ensure data entered into cases is complete, accurate and of high quality to enable BIU to produce product quality trending reports for product improvements.

Takes ownership of complaints / potential complaints and works on resolution with the CCSC, RTAC, FSE and BIU within the appropriate timeframes.

Understands the service delivery process and FDA regulations such as 820.200, 820.198.

Able to perform responsibilities and assigned tasks with minimal supervision.

Entry level project participation / management including CAPA's, Kaizen and LEAN training.

You are responsible for:

The person fulfilling this role is responsible for service record review ensuring quality records, identifying potential FDA reportable events and Business Unit follow up and escalation.

This role is also responsible for corresponding with the Customer Care Solutions Center and Field Service Organization to ensure a complete and quality record.

Reviews corrective maintenance cases for completeness and accuracy.

Ensures that all or the required safety information is answered.

Works with field service and RTAC directly to document complaint records.

Interfaces with the business unit on coding and escalations.

To succeed in this role, you should have the following skills and experience:

Experience in an administrative position with experience in a similar documentation / data driven position.

A BS/BA or equivalent experience in business preferred.

Familiar with FDA regulations.

Well versed in Q&R medical device terminology.



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