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 PEC.COM 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
ØEstablish compliant, efficient and lean design control process in China PEC.COM 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
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
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