Plan, lead and coordinate internal audit activities, e.g. meeting with internal auditor to discuss the audit plan, compile internal audit report, review CAR with QMR, verify effectiveness of CAR action and closure, etc.
Plan schedule and coordinate internal team based on the audit schedule, e.g. liaise with 3rd parties for audit schedule, coordinate with internal team to ensure the audit CAR until closure, etc.
Support for Customer Audit and Product Safety audit, e.g. perform audit; liaise with 3rd party (if any), respond CAR for non-conformances, etc.
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Responsible for coordinating revisions to Acceptance Procedures with Masimo Corporate;
Ensures that required inspection equipment is available, maintained, and calibrated;
Initiates actions required to prevent and/or eliminate the occurrence or recurrence of all nonconformities relating to the product, process, and/or quality system.
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This role requires someone who is comfortable working directly on the production floor, analyzing quality data, driving corrective actions, and working cross-functionally with Production, Engineering, Purchasing, Warehouse and subcontractors.
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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