Head of QRA--某500强欧洲医疗企业亚太研发中心

Responsibilities/ Authorities

General responsibilities:

ØEstablish a strong team that will be able to cover all quality and test related tasks within the GRD for machine development in the country and region.

ØDevelop senior managers capable of covering the topics within the sub-teams o Ensure suitable team size, training and motivation.

ØEstablish positive team culture

ØEnsure an appropriate, high quality level of products and components suitable for company brand, but also keep the special focus on cost optimized design and manufacturing

ØBe a strong, proactive manager and team member of the company and work on joint targets to ensure overall teams success. Co-work on teams strategy.

ØCooperate with the region and manufacturing teams as well as GRD teams in overseas (such as AP RA team, CN RA team, DE RA team, German product center, Headquarter QA team, etc.) o Be responsible for product risk management.

ØSupport other PECs on quality and registration related questions especially related to China o Represent the R&D team to face external audits

ØWork closely with project teams, gather relevant information, report status.

ØSupport to establish the international product center concept for product maintenance including sustaining engineering, complaint tracking etc

ØCooperate with existing teams and establish a working interface with relevant CFDA bodies e.g. test centers

ØParticipate in China standard committees relevant for dialysis o Manage GRD labs and ensure availability of in-house necessary equipment including calibration

ØEstablish a network with external partners for external testing


Design controls:

ØEstablish compliant, efficient and lean design control process in China  team, ensure appropriate training level

ØReviewing and approving design documents, performing internal audit to ensure the development meet ·process requirement


ØEstablish working environment to know and test according to China and international standards o Plan and perform verification testing for development projects and product changes

ØEnsure suitable amount of automated testing

ØImplement efficient means for software and system test


Reliability engineering:

ØEstablish relevant methods and tools to plan reliability engineering tests to ensure product quality over a specified life time

ØSetup appropriate internal and external testing capabilities


Registration support:

ØProvide professional knowledge and experience for HD machine registration for project development teams

ØDrive GRD registration projects, including schedule and action plan for new products or product changes;

ØPrepare and maintain R&D related product registration dossiers complying with all requirements; Participate as sub project manager or lead sub project managers to achieve ·timely product registration for Chinese market



ØMinimum Bachelor Degree in engineering, or related degree

Ø6 or more years of experience in several quality related functions (design controls, testing, reliability engineering, regulatory, risk management)

ØMust have working knowledge of SFDA, ISO and related regulations;

ØDeep understanding of Design control process

ØGood project management, problem solving and decision making skills;

ØFluent in both spoken and written English and Chinese; Excellent communication skills.

ØBe comfortable working in a changing environment which requires flexibility and involves risk.

ØBe comfortable working under pressure

ØPragmatic and proactive mindset