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EN-DT00041
Job Summary
 
Job Type : any
Location : Bangkok Huay Khwang , Thailand
Salary (THB/month): 70 k - 100 k
Minimum Experience: 5 years
Education : Bachelor
EIT Job Id : EN-DT00041
Job Function :
QS
Open to :
Thai national Only
 

Quality Assurance Manager , Thailand & SEA

Job Description
Our client is the global leader in the science of heart valves and hemodynamic monitoring. Now, more than 50 years later, the company has grown into a global company with a presence in approximately 100 countries and more than 7,000 employees around the world.

Role Purpose :
The Quality Manager will be responsible for the key quality functions within Thailand and SEA, support in warehousing activities, oversight in supply chain activities, implementation of Internal audit procedure and providing inputs in AP management review process.

Job Functions :
Ensure that the Quality Management System (QMS) is effectively established, implemented and maintained to be in compliance with ISO13485, 21 CFR 820, and other relevant regulatory requirements in Thailand and SEA, and all other applicable requirements.

Essential Job Functions :
- 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 the region, to report out the performance of the quality system to Management with executive responsibility for review and any need for improvement.
- Oversees Management and execution of Field Actions in the region /ensure notification to appropriate reporting channel of significant issues presenting significant health risk.
- Establish and maintain the effective complaint handling process, under Edwards Quality Management System.
- Responsible for Quality linked to Warehouse and Distribution for the region (mainly Third Party Logistic Companies).
- Responsible for the Management of CAPA for the country.
- Ensure evaluation / approval / control of all Edwards Lifesciences suppliers marketing product/services in the region by determining the risk level of supplied product / verification of Edwards brand guiding principles / performing supplier assessments.
- Ensure contract review requirements are met / approved for all Edwards suppliers in the region.
- Implement a robust process to better control and manage Distributors

Marginal Job Functions :
- Provides expertise and guidance in interpreting and implementing appropriate country regulations, agency guidelines and internal policies to assure compliance.
- Supports company goals and objectives, policies and procedures, QSR, and regulations.



Job Qualification
Required Education/Skills/Experience :
- Education: Bachelor’s degree or related degree in a scientific field required – preferably in medical expertise and Quality Management. An advanced degree (i.e. Master, PhD) is a plus. Good Management / Leadership / Risk Management, Analytical and Communication skills essential. Solid understanding of Quality Systems, National regulatory requirements. PC skills required.
- Languages of Thailand and English essential, any additional language is a plus.

Experience :
- Minimum of 5 years professional experience in Quality Management in a medical or pharmaceutical Quality environment. Experience of working with US companies/exposure to US environment. Preferably with some experience in a manufacturing site.
- Knowledge in process validation and risk management.
- Adequate 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.

Personal characteristics :
- Ability to work effectively with diverse cultures and able to promote information across functional areas both within the candidate’s region and globally
- Ability to make tough and difficult decisions and to drive implications with integrity and consistency
- Resiliency to adapt to change and implement changes rapidly, always seeking continuous innovation and improvement
- Good organization and analytical abilities, ability to interact effectively with all levels of staff, stable personality and high sense of responsibility, professional image and work ethic.
- Able to work under pressure and able to work at different activities at the same time
- Good analytical skills
- Excellent communication skills in Languages of Thailand and English

"Must Have" in Candidate qualifications


- Did you Bachelor’s degree or related degree in a scientific field required – preferably in medical expertise and Quality Management. An advanced degree (i.e. Master, PhD) is a plus ?
- Did you Good Management / Leadership / Risk Management, Analytical and Communication skills essential ?
- Did you Solid understanding of Quality Systems, National regulatory requirements.
- Do you have spoken written and reading in English (good level)?