The Site Quality Engineer is primarily responsible for the overall quality satisf of the customer base, for ensuring establishment of processes that consistently deliver best-in-class quality and for instilling quality awareness in the cross functional team(s). The role includes the assessment of quality, reliability and satisf levels driving cross functional and cross organizational teams to improve quality failure analysis design of experiments inter with engineering, manufacturing, NPT teams, contract manufacturing partner(s), customers and the business units utilizing structured problem solving tools and techniques and the completion of tasks and ives that support quality improvement.

Key Responsibilities: (Bullets)

•Monitor and report the performance of products in market by analyzing customer feedback, files of authority, and service report
•Perform trend analyses through non-conformance monitoring, identify issues, drive to root cause and implement robust corrective s
•Directly and timely communicate with customer for quality and technical issues
•Improve efficiency of customer quality feedback system by coordinating between commercial channels and manufacturing forces
•Plan or participate in validations
•Represent the Quality Department in cross-functional teams and activities such as daily stand up meeting, gemba walk, etc.
•Perform cross-departmental audits include process and product audit
•Review engineering change from product compliance aspect Manage document control system.
•Understand applicable regulations, guidelines and standards related to product and disseminate Regulatory Affairs communication.
•Follow, interpret and create written Standard Operating Procedures (SOP’s) or Working Instructions
•Conduct trainings on Quality-related items (i.e. GMP, ISO, etc)
•Organize RGA process cross-functionally



Minimum Requirements/Qualifications: (Bullets)

•Major in engineering with bachelor degree or equivalent
•3 years above experiences in manufacturing, product development or technical service environment
•Professional technical or engineering experience laboratorial instrument industry or multi-technologies know-how will be preference
•Knowledge and experience on Lean manufacturing
•Strong inter-personal skills
•Excellent oral and written communication skill in English, be able to work in a multicultural environment
•Implementation experience in ISO9000 or ISO13485
•Ability to achieve goals independently within a challenging time .
•Project management skill
•Ability to handle conflict with confidence and integrity

Bonus Qualifications (not explicitly required):
•Histology experience
•Experience with quality systems in an IVD/Medical device environment

Non-Negotiable Hiring Criteria: (Bullet 3-5 key quantifiable skills or position requirements that the candidate must have to be considered for this position.)

Strong knowledge on data analysis (Pareto Chart, Control Chart) and CAPA
Major in engineering with bachelor degree or equivalent
Ability to achieve goals independently within a challenging time .
Ability to handle conflict with confidence and integrity
3 years above experiences in manufacturing, product development or technical service environment
Excellent oral and written communication skill in English, be able to work in a multicultural environment

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.