Prepare and submit MDR reports to FDA ? Summarize findings, including a review of the investigation, product analysis, imaging review, instructions for use (IFU), and any other relevant labeling and/or training materials, and formulate conclusions ? Prepare and submit final customer correspondence ? Assist in planning agendas and running weekly meetings to discuss complaint issues with affected functions .
April 27, 2022
Manages the inspection readiness program for the site, while ensuring compliance with the QMS and all local/global regulatory requirements for the scope of work defined in the SLA and/or Quality Agreement.
November 09, 2022
Assists in the collection and analysis of a wide range of institutional data that will be used to establish benchmarks and to support decision making, problem solving and planning for continuous quality improvement.
December 01, 2022
Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition.
December 16, 2022
Support execution of the supplier quality program, including, qualifications and/or audits, routine monitoring, assessment meetings, action requests and as necessary, issue resolution.
January 03, 2023
Develop and implement a standardized training process that complies with all regulatory/corporate requirements (GMP focus) by working with site functional leads, Quality CoE Training & Capabilities Manager, Corporate QA, and training peers to develop processes, tools and templates to deliver a standardized approach.
January 22, 2023
Lead the investigation/CAPA triage meetings (as necessary) and collaborate with customer groups to ensure quality systems are monitored and established metrics are met.
February 27, 2023