Job Description
**What you will do:**
+ Independently manage and ensure compliance with the assigned QMS functions in line with of ISO 13485:2016 requirements.
+ Management of Site Validation Program including execution and review of Validation activities of equipment, Processes, Test Method, facilities and utilities and computer system
+ Handle Deviation, Risk Assessments, and Out of Calibration Results in accordance with established procedures.
+ Review and monitor Preventive maintenance and AMC schedules ensuring timely execution and compliance.
+ Coordinate and support Change Management activities
+ Track, Analyze and report on Key Performance Indicators (KPIs) to ensure adherence to processes and prevent non-conformity relating to product, process or system.
+ Perform data analysis using various statistical tools to support quality decision making.
+ Work closely with cross-functional teams to ensure site compliance...
+ Independently manage and ensure compliance with the assigned QMS functions in line with of ISO 13485:2016 requirements.
+ Management of Site Validation Program including execution and review of Validation activities of equipment, Processes, Test Method, facilities and utilities and computer system
+ Handle Deviation, Risk Assessments, and Out of Calibration Results in accordance with established procedures.
+ Review and monitor Preventive maintenance and AMC schedules ensuring timely execution and compliance.
+ Coordinate and support Change Management activities
+ Track, Analyze and report on Key Performance Indicators (KPIs) to ensure adherence to processes and prevent non-conformity relating to product, process or system.
+ Perform data analysis using various statistical tools to support quality decision making.
+ Work closely with cross-functional teams to ensure site compliance...
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