Educational Qualifications/Experience
-B.S Engineering or above biological or pharmacy related is preferable.
-Technology or quality experience on manufacturing processes, key quality control point of biological and pharmaceutical factory is preferred
-Working knowledge of ISO13485,GMP
-Fluent verbal and written English
-Good communication skill and team work spirit
-Strong problem solving skills
-Need to travel extensively to visit suppliers


Supplier Development Engineer Basic Function
•Provide sourcing recommendations for the current suppliers and involvement with global sourcing and product transfer projects.
•Make sure supplier understands all requirements (engineering, quality and program timing etc.)
•Lead the implementation of the Supplier Quality Manual. Make sure supplier follows ASQP process and project timing requirements are being met
•Ensure the supplier sets up robust manufacturing process for producing parts
•Supplier quality performance monitoring and continuous improvements,
•Provide immediate containment and proper controls at the supplier and use quality tool (FMEA,CpK,GR&R,SPC,ect) to do root cause analysis for quality issues and drives the continuous improvement at the supplier site
•Function as a liaison between R&D, Purchasing, Manufacturing, and suppliers to resolve supplier quality issues and to provide technical support

Responsibilities:
•Audit & develop new suppliers for the biological, chemical and plastic supplier
•Assist in the implementation and monitoring of advanced product quality planning with ed suppliers
•Ensure supplier understanding of product, engineering specification, quality, program timing and submission requirements
•Review and approve supplier quality plans on new part programs
•Review and assure supplier set up robust manufacturing processes and quality systems
•Implement and monitor the part qualification and certification process with suppliers
•Determine cause of supplier quality problems and coordinate/implement effective and timely resolutions.
•Assure supplier process control planning. Determine part critical characteristics and required process controls
•Assure tier 1 supplier has good controls on sub-tier suppliers
•Approve supplier production trial run, part dimension measurement, material and functional tests, process capability studies, and PPAP submission
•Process Control Plan uation and Audit
•Continuously improve quality performance of suppliers by conducting workshops at supplier s, providing technical assistance in developing a quality system, or other technical support as required
•Quality and delivery performance monitoring, communication, risk identification and escalation to drive correction before impacting TCO.
•Maintain required documentation and files as per requirements
•Implement and monitor supplier metrics
•Other tasks assigned by manager

About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services. For more information, please visit www.thermofisher.com.