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.
Monitor relevant standards, industry regulations, and customer requirements for data centres and liquid-cooling equipment. Update internal controls to ensure continued compliance with RoHS, REACH, halogen-free, and other requirements.
Manage third-party certification, surveillance, and recertification audits, including preparation, documentation, on-site coordination, corrective actions, and closure verification.
Prepare annual internal audit and management review plans. Conduct system and cross-departmental compliance audits covering R&D, production, supply chain, warehousing, and delivery.
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Leads and participates in problem solving activities related to manufacture and inspection and test, including NCR and supplier related issues
Communicates significant issues or developments during quality inspection activities and through analysis provides plans and recommendations to the team and management for resolution
Leads and/or participates in IQ/OQ and PQ activities, test sample size selection, test method validations, Gage R&R studies and risk management activities to assure conformance to product quality standards and applicable regulations
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Leads and participates in problem solving activities related to design, manufacture and inspection and test, including CAPA, NCR and supplier related issues
Communicates significant issues or developments during quality inspection activities and through analysis provides plans and recommendations to the team and management for resolution.
Review and verify completeness and accuracy of Device History Records (DHRs) to ensure all manufacturing, inspection, and testing activities are properly documented and meet product specifications and regulatory requirements
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Ensure, through training and verification, the appropriate use of current documentation, as well as the use of good documentation practices during all the stages of manufacturing.
Ensure and monitor the applicable documents for Quality inspection are available in the point of use, this includes, but is not limited to the visual aids with physical samples.
Continuously assess and improve incoming quality inspection processes to enhance efficiency, accuracy, and reliability. Identify opportunities for automation and optimization to streamline workflows
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Leads and participates in problem solving activities related to manufacture and inspection and test, including NCR and supplier related issues
Communicates significant issues or developments during quality inspection activities and through analysis provides plans and recommendations to the team and management for resolution
Leads and/or participates in IQ/OQ and PQ activities, test sample size selection, test method validations, Gage R&R studies and risk management activities to assure conformance to product quality standards and applicable regulations
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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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Provide hands-on technical support and guidance to our suppliers, particularly in areas such as manufacturing of PCBAs, Power Supplies, and other electronic components.
Validate Supplier Production Processes as part of New Product Introduction (NPI), Engineering Change Note (CN) and Supplier Change Requests (SRFC).
Investigate and resolve supplier quality issues, driving root cause analysis, managing corrective actions (CAPA), and continuous improvement.
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Provide hands-on technical support and guidance to our suppliers, particularly in areas such as manufacturing of PCBAs, Power Supplies, and other electronic components.
Validate Supplier Production Processes as part of New Product Introduction (NPI), Engineering Change Note (CN) and Supplier Change Requests (SRFC).
Investigate and resolve supplier quality issues, driving root cause analysis, managing corrective actions (CAPA), and continuous improvement.
...
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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Learn and master the inspection standards for key raw materials and components of MV/LV switchgear, including but not limited to: enclosure sheet metal, copper busbars, insulation parts, circuit breakers, current/voltage transformers, meters, busbars, and cables.
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