Job De****ion:
1) Support Quality Manager to be accountable for KPI of Draeger global and to create/maintain the quality KPI of regional Operation organization.
2) Liaison with Operation management to ****uate, implement, improve and optimize the quality system management processes owned by SDMI and DSEC Operations.
3) Drive the quality monitoring and analysis in production lines and ensure the production quality always under controlling.
4) Audit or review internally all kinds of processes relevant to production quality and mitigate the risk from external audit from TUV or SFDA.
5) Effectively work with cross function to create the quality plan in the early stage of production process.
6) Create and review the statistic quality reports and drive for improvements
7) Management and coordination of all ship and production holds ****s in Operations initiated by PQM
8) Customer satisf**** and Complaint analysis.
9) Functional support or training for the Production Quality Engineers.
10) Support of SQA to indicate/report and solve material problems and support the First Article Inspection Process.
Job Requirements:
Education:
Bachelor degree or above in engineering
Certificate of Internal Auditor
Related Experience
1) >= 6 years working experience
2) >= 4 years working experience in quality and preferred in medical production
3) >= 3 years experience leadership.
4) Experience with product like respiratory, gas detection and / or hazard protection / insulation is preferred
Professional Skills,
1) Good knowledge of ISO 9001 is a must
2) Knowledge of ISO 13485 and MDD is preferred
3) Knowledge of SFDA regulation is better
4) Knowledge of quality tools (such as, SPC/6-sigma)
5) Knowledge and skill for quality reporting and presentation.
德尔格是医疗和安全技术的国际先行者。德尔格 于 1889 成立于吕贝克,作为一个家族经营的企业已经历经第五代,走向了全球并且列入 DAX 指数。我们的长期成功来自于以价值为中心的公司文化和四种核心优势:与客户紧密合作、员工的专业知识、不断创新和卓越的质量。
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