Edwards Lifesciences Manager, Quality in Kuala Lumpur, Malaysia
Implement/Maintain Processes under Edwards Quality Management System, to meet Regional Regulatory Requirements, while contributing to the international markets' growth for SEA countries (Except Thailand).
a) Plan and lead the execution of Quality projects and activities (e.g., Quality Assurance, Quality Engineering, Quality Systems, Supplier Quality) with accountability for successful completion within scope of project deliverables.
b) Provide direction and guidance to smaller project teams to execute tactical Quality projects and/or initiatives.
c) Develop, lead, and/or contribute to the implementation of proposed modifications to resolve open issues, as a part of cross-functional / project team, to bring the process knowledge.
- Distribution Center Quality Management
a) Implement and maintain Product Inspection Process and Product Release Process, including Imported Finished Goods and Returned Products
b) Implement and track Quality Hold in 3PL
c) Plan and Execute improvement program for 3PL Quality Management System, implement and maintain Quality Agreements
- Quality Management System
a) Maintain Quality Management System according to Edwards and local regulatory requirements
b) Maintain GDPMD Certification for Malaysia Market
c) Work with cross-functional team on NCR, CAPA, and Product Risk Assessment (PRA) Process, including the required document preparation in a timely manner. Follow up CAPA and SCAR action plan
d) Provide Quality Training
e) Implement Supplier Control Process
f) Execute the action plans and ensure successful implementation of Quality goals
Participate in supplier, internal audit, external and distributor audit program
Post Market Quality Assurance
a) Product Complaint Handling Process, includes overview of reporting complaints to CH Center, following up Complaint Investigation, and support in preparing Customer Response Letter in Local Language if required.
b) MDR process: Assess reportable complaints and report ADE to Competency Authority according to Local Regulation.
c) Field Corrective Action Process, includes operations in JDE system. Act as Local FCA Coordinator.
- Effective tracking and implementing all new regulations related to Quality Management system
Marginal Job Functions
- Other incidental duties: Implement continuous improvement program or project assigned by manager
Education and Experience:
Bachelor's Degree in or related degree in a scientific field, preferably in medical expertise and Quality Management, 8 years years experience professional experience in Quality Management in a medical or pharmaceutical Quality environment Required and
Experience of working with US companies/exposure to US environment Required
Master's Degree or equivalent Experience in a manufacturing site Preferred
• Proven successful project management skills
• Proven expertise in both Microsoft Office Suite, including advanced Excel and Quality systems
• Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards
• Extensive knowledge in process validation and risk management
• Extensive understanding of Quality Systems, National regulatory requirements
• Extensive knowledge in ISO 13485, 21 CFR 820, 21 CFR 11, the relevant regulatory requirements in country, and all other applicable requirements.
• Experience of FDA Inspection / Local Inspection preferred
• Excellent documentation( root cause investigation) and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Fluency in English languages required; other additional language preferred
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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.