Participate in establishing the quality management system according to ISO 9001:2015 standard.
Review and validate process design considering workflow, cycle time, and document control requirements.
Prepare and plan for audits.
Conduct Planned and random audits and report the findings.
Follow up on the CAPA plan with the process owner.
Prepare for and follow up on the result of the Management Review Meeting.
Contribute to process performance analysis and process capability assessments.
Participate in process improvement initiatives.
Develop Key Performance Indicators and service level agreements for processes based on the best practices.