职位描述
职位描述：
Job purpose:
· Build up and standardize the manufacturing(Machining) process
· Provide technical support on daily production operation
· Solving the problem regarding Machining process and related quality issues
Implement lean transformation, continuously improve production efficiency
Areas of responsibility:
Compliance and adherence to, at all times, applicable laws and regulations (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 regulations within China and those applicable to Elos Medtech Tianjin’s operations
· Elos Medtech Group’s Quality and Environmental Policies
· Elos Medtech Group Values and Our Ways
· Others as it is applicable
Functional management:
· Technical management and development in machining process.
· New product and process development and design.
· Build up and standardize the manufacturing(Machining) process
· Be responsible 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 leaders and operators 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, ensure corrective and preventive actions are taken and effective
· Support on customer complains 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 transformation, 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
Qualifications and Desired Skills
· Bachelor degree or above, manufacturing or mechanic relevant major
· 10 years 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 Seimens)
· 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
