工作職責(zé)：
?The position is accountable for regulatory (GMP & GSP) and company’s quality system compliance associated with commercial, sourcing and planning team, thus to ultimately ensure the compliance of products purchasing and selling process.
?Develop and enhance supplier & dealer quality in compliance with ISO13485, GSP regulations and company requirements.
?Support QMS processes such as CAPA, QMS Audit and so on.
? Lead or support QMS processes such as CAPA, management review, internal & external audit.
?Support commercial, sourcing and planning team to establish and improve sales order and purchasing order handling process to fully comply with regulatory, ISO13485 and company requirements
?Establish quality agreements with supplier (internal/external) and customer’s.
?Establish and maintain supplier & dealer quality process and procedures to meet company policies and regulatory requirements.
?Develop and deliver training to internal teams and suppliers & dealers, influence and enhance organization’s quality & compliance awareness for supplier & dealer management.
?Support to perform risk classification, ion, uation and qualification of suppliers per purchasing control requirements and oversee their status on the approved supplier list (ASL).
?Be responsible for maintaining supplier & dealer annual audit plan, conducting and overseeing audits execution as well as finding and supplier & dealer CAPA closure.
?Be fully engaged in internal & external audits for related processes.
任職要求：
?Health care industry 4+ years quality experience
?2+ years of practical medical device QMS experience is preferred.
?Comprehensive understanding and hands on experiences on ISO13485. Certified lead auditor is a plus.
?Working knowledge of CFDA medical device GMP&GSP regulations and understand how to interpret and implement them in company’s quality process.
?Understanding and implementation experience in problem solving with quality tools is preferred, such as: FMEA, control plan design, process capability improvement, 8-D/CAPA/5WHY, etc.

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.