Job Description

Key Responsibilities:

• Establish / Control / Ensure training on Quality Assurance Systems, policies, processes, procedures consistent with Edwards Global Policies ensuring that the quality of products are conform to established standards and regulatory requirements.
• Responsible for Internal/External Audits, providing inputs in Quarterly Management Review for Malaysia, to report out the performance of the quality system to Management with executive responsibility for review and any need for improvement.
• Establish and maintain the effective complaint handling process, under Edwards Quality Management System
• Responsible for Quality linked to Warehouse and Distribution for Malaysia (mainly Third Party Logistic Companies).
• Determine the risk level of supplied product / verification of Edwards brand guiding principles / performing supplier assessments while ensuring evaluation, approval, and control of all Edwards Lifesciences suppliers marketing product/services in Malaysia by
• Ensure contract review requirements are met / approved for all Edwards suppliers in Malaysia
• Provides expertise and guidance in interpreting and implementing appropriate country regulations, agency guidelines and internal policies to assure compliance
• Other duties assigned by Leadership. Supports company goals and objectives, policies and procedures, QSR, and regulations

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

Additional Skills:

• 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 and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Fluency in Thai and English languages required; other additional language preferred
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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

About Edwards Lifesciences

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\xe2\x80\x99s 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 13,000 individuals worldwide.

For us, helping patients is not a slogan - it\xe2\x80\x99s our life\xe2\x80\x99s 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.

COVID Vaccination Requirement

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.

For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Know your Rights: Workplace Discrimination is Illegal Poster
Disability accommodation for employment applicants
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Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
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