Coordinate and monitor Corrective and Preventive Actions (CAPA).
Review and approve quality documents including SOPs, work instructions, inspection standards, validation protocols, and engineering change documentation.
Support internal, supplier, and external audits, including customer and regulatory inspections.
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Issue, monitor, and verify Supplier Corrective Action Requests (SCARs).
Review and approve First Article Inspection (FAI), Control Plans, Process Flows, and Material/Test Certificates.
Investigate supplier quality issues and coordinate with Purchasing, Engineering, Production, and other relevant departments to implement corrective actions.
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Ensure risk of non-compliance and related business risks are mitigated
Provide quality / technical leadership through mentoring/coaching
Ensure compliance to ResMed QMS; strong knowledge, application of and compliance to FDA Quality System Regulations, GMP, and applicable ISO / regulatory standards
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