品保人員

1.Responsible for improving current QMS procedures in conformity to regulatory requirements from FDA QSR (21 CFR Part 820), ISO 13485 and GMP.
2.Collaborate with Design & Development functions to ensure qualified documentation of DHF and DMR.
3.Collaborate with Manufacturing functions to establish and implement procedures related to production quality control.
4.Lead routine validation, re-validation and monitoring activities including but not limited to manufacturing processes such as EO sterilization, packaging, and facility maintenance such as equipment, cleanroom HVAC, and bio-burden monitoring.
5.Participate in external quality inspections and execute internal and supplier audits.
6.Participate in risk management activities throughout product life cycle and generate required documents and records.

• 職務類別：品管／製造／環衛 / ISO/品保人員
• 職務性質：全職
• 工作地點：新竹市新竹市
• 工作時間：日班
• 工作經驗：5年以上
• 學歷要求：大學
• 薪資：依學經歷、證照核薪(每月經常性薪資達4萬元以上)
• 需求人數：2
• 應徵截止：2026-11-30

資料來源：勞動部勞動力發展署「台灣就業通」（政府資料開放授權條款第1版）