The role of the QA Compliance Specialist is to execute and monitor all Quality Systems within Alcon Huntington to include: Client Quality Manual implementation, Alcon Global Quality Manual implementation, CAPA effectiveness, audit support (external and internal), metrics/KPI reporting, Quality Plan implementation, management review, and Quality Risk Assessment (QRA) programs.
Major Accountabilities(Describe the 5-7 main results of the role to be achieved )
Support implementation of Regulatory Authority, Client and Alcon Divisional Quality System requirements through gap assessment activities.
Generation and collection of system metrics and measurements to support the ongoing maintenance of site compliance. Collaborate with Alcon Division Quality System and Compliance groups to ensure consistent metric reporting across Surgical business unit.
Collection, preparation, and presentation of Compliance data and trend reports for Quality Management Reviews. Compilation of Quality Management Review minutes and final report, and oversight of follow-up activities.
Execution and monitoring of Site Quality Plan objectives.
Champion continuous Quality System improvement and effectiveness. Maintain a detailed knowledge of the Medical Device regulations, guidance and requirements. Promote awareness of best industry practices, providing company training as required.
Participate in audit readiness and execution activities as required. Monitoring of audit follow-up activities.
Key Performance Indicators (Indicate how performance for this role will be measured)
On-time completion of compliance objectives, including metric reporting, gap assessments, and Quality Management Review closure
Maintain compliance with Regulatory Authority, Client and Alcon Divisional Quality System requirements
On-time completion of external audit follow-up activities