Edwards Lifesciences Sr. Specialist Quality in Kuala Lumpur BSC, Malaysia
Assess technical service center quality and compliance level. provide recommendations and drive appropriate actions including but not limited to, escalation through the Non-conformance, CAPA and PRA processes.
Review and approve the Validation Plan/documentation as Quality Engineer
Assess the readiness of facility, processes, and people qualification from quality compliance for new product launch
Partner with FCA coordinator to execute FCA related to TSC
Change leader of Trouble Shooting RBM
Approver of Calibration/ Maintenance plan in Maximo as SQE
Support the tech service team in the identification, development and execution of continuous improvement projects ensuring global standardization and compliance
Manage technical service project quality activities with the accountability for successful completion of all deliverables to the business within established schedule, scope and quality objectives.
Partner with cross functional groups to identify risks, develop mitigation strategies, alternative solutions, resolve issues, action item follow up
Collect and generate metrics, and draw inferences for system improvement opportunities
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.