Areas of respoibility:

Compliance and adherence to, at all times, applicable laws and regulatio (norms) and internal Group and local and policies – particularly:

· ISO 13485

· FDA part 820 QMS

· FDA Part 11, Electronic Records; Electronic Signatures — Scope and Application

· ISO 14001

· Laws and regulatio within China and those applicable to Elos Medtech Tianjin’s operatio

· Elos Medtech Group’s Quality and Environmental Policies

· Elos Medtech Group Values and Our Ways

· Othe as it is applicable

Functional management:

· Establish manufacturing process, develop and update process file

· Build up and standardize the manufacturing(Machining) process

· Be respoible for Fixture & Jig designing, purchasing and maintenance, risk evaluation for process change of new tooling/equipment

· Develop, maintain and improve manufacturing documents, such as PFMEA, Procedure, SOP, WI

· Train shift leade and operato for procedures, SOP and WI

· Provide technical support and training about Machining process

· Handle daily deviation report and lead process problem solving and root cause analysis, eure corrective and preventive actio are taken and effective

· Support on customer complai handling and provide technical support in regards to process problem solving and root cause analysis

· Participate in NPI project as Manufacturing technical expert, lead Machining line designing/lay-out and Manufacture build

· Implement lean traformation, participate in RIE, continuously optimize manufacturing process

· Assist on production equipment maintenance and upkeep

· Implement process continuous improvement project for cost reduction and productivity increasing and quality increasing

· Promote and improve workshop 5S management

Other tasks that are assigned by Manufacturing Manager

Qualificatio and Desired Skills：

· Bachelor degree or above, manufacturing or mechanic relevant major

· 5 yea and above experience in related area of manufacturing factory with solid theoretical knowledge and practical experience & skill

· CNC working experience is must, including manually programming for CNC turning& milling compound machine (FANUC or Seime)

· Be familiar with mechanical parts measurement technique, can choose proper tools and methodology

· Quality management capability and quality awareness is required

· AutoCAD skill required, UG modeling skill is preferred

· Experience in foreign investment enterprise is preferable

· Medical device background is preferable

· CET4, good English capability in listening, speaking and written

· 5S and lean experience is preferable

Good teamwork spirit, passion, trustworthy, result-oriented, detail oriented and able to work under pressure