Associate quality systems specialist

Descripción del cargo

Responsibilities may include the following and other duties may be assigned:

Contributes to the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance with policies and that service performance and quality meet established internal and external standards and guidelines.

Ensure personal understanding of all applicable elements of the Quality Policy/Quality System.

Follow all quality and work procedures to ensure compliance with the Quality System and the delivery of high-quality work.

Foster cross-functional collaboration and mutual understanding of product recalls and Field Corrective Actions (FCAs).

Produces the necessary FCA document packages to be used by Global FCA Coordinator(s) and Region/Country QARA stakeholders.

Ensure coordination with the Global FCA Coordinator(s) regarding actions to be taken with stakeholders responsible for FCA Planning, Execution, and Closure.

Resolve issues as necessary to complete daily work activities.

Provide analytical support for key metrics and operational reporting.

Maintain all FCA documentation within the appropriate quality system(s).

Act as a change agent for the organization. Identify, facilitate, and implement changes to improve efficiency, ensure compliance, and reduce process complexity as needed.

Participate in and support Quality System audits within the regions served.

Operate in environments that comply with Quality System requirements



Required Knowledge and Experience: 

Bachelor's degree

Fluent in English

1 year of QMS and Field Action/Recall in the Medical Device field

1 year of experience in quality systems

1 year of experience with FCA documentation