Associate Quality Systems Specialist
Core
Develop and maintain quality programs, systems, and procedures to ensure compliance with policies and standards for medical device field actions and recalls.
Role type
Associate Quality Systems Specialist
Builds
FCA document packages and operational reporting for global stakeholders
Domain
Medical device quality systems and field corrective actions
Required skills
Quality system compliance, FCA documentation, cross-functional collaboration, analytical support, process improvement, audit participation, change management
Preferred skills
null
Technologies
null
Responsibilities
Contribute to the development and maintenance of quality programs, systems, processes, and procedures; 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; Foster cross-functional collaboration and mutual understanding of product recalls and Field Corrective Actions (FCAs); Produce 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
Seniority
Associate, entry-level IC