1.汽車產業品質管理系統,具ISO9001 or IATF16949 or VDA等認證。 2.了解VDA標準(包含VDA6.3、VDA2、VDA5),具備主導審核及實施相關標準的能力。 3.熟練汽車業核心品質工具:APQP、FMEA、SPC、MSA及PPAP。 4.具製程稽核實務經驗,能提出品質優化方案。 5.應對客戶品質稽核,進行品質文件審查與回饋。 具備三年以上汽車相關產業工作經驗。
1. Plan, implement and coordinate activities related to quality system, quality assurance, quality verification, customer problem handling and daily management of the department. 2. Collection and update of domestic/foreign medical device regulatory certifications and related regulations and standards. 3. ISO13485 and GMP quality system audit related matters. 4. Matters related to domestic/foreign medical device clinical trials.