Apply established Manufacturing QA standards, methods, playbooks and tools to support consistency, standardization and adoption of proven approaches across manufacturing teams.
Use quality and manufacturing data, including NCP/CAPA learning, validation outputs, audit findings and process performance signals, to identify trends, support investigations, recommend preventive actions and contribute learning to future Quality Engineering solutions.
Contribute to continuous improvement of manufacturing quality systems, processes and engineering practices, supporting improved Right First Time performance and reduction of repeat or systemic quality issues....
Analyze manufacturing and quality data to identify systemic risks, reduce recurrence of issues, improve Right First Time performance, and strengthen future manufacturing designs.
Support quality activities for automation, MES, digital quality systems, software-enabled manufacturing processes, and digital assurance initiatives.
Develop and implement manufacturing quality strategies, readiness plans, and preventive control mechanisms that support sustainable compliance and operational performance....
• Support manufacturing readiness activities, including quality planning, risk assessments, validation activities, digital assurance/CSV/CSA deliverables where applicable, control strategy execution and launch/post-launch learning.
• Apply established Manufacturing QA standards, methods, playbooks and tools to support consistency, standardisation and adoption of proven approaches across manufacturing teams.
• Use quality and manufacturing data, including NCP/CAPA learning, validation outputs, audit findings and process performance signals, to identify trends, support investigations, recommend preventive actions and contribute learning to future Quality Engineering solutions....
Apply established Manufacturing QA standards, methods, playbooks and tools to support consistency, standardization and adoption of proven approaches across manufacturing teams.
Use quality and manufacturing data, including NCP/CAPA learning, validation outputs, audit findings and process performance signals, to identify trends, support investigations, recommend preventive actions and contribute learning to future Quality Engineering solutions.
Contribute to continuous improvement of manufacturing quality systems, processes and engineering practices, supporting improved Right First Time performance and reduction of repeat or systemic quality issues....
Monitor supplier quality performance metrics and trends, escalating emerging quality signals and trends to appropriate leaders and stakeholders in a timely manner.
Initiate programs to improve supplier performance systematically and reduce cost of poor quality, utilizing digitalization and data analytics
Ensure timely communication of issues that affect supplier quality and delivery capability to the relevant stakeholders across the organization....
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...
Monitor supplier quality performance metrics and trends, escalating emerging quality signals and trends to appropriate leaders and stakeholders in a timely manner.
Initiate programs to improve supplier performance systematically and reduce cost of poor quality, utilizing digitalization and data analytics
Ensure timely communication of issues that affect supplier quality and delivery capability to the relevant stakeholders across the organization....
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...