品質管理經理

〔Job Profile〕
此職務主要協助品保團隊進行品質系統的整合、導入、維護與持續改善工作，以確保公司服務、產品和流程符合相關法令與法規要求(例如CAP, LDTS, ISO 15189, ISO 27001, ISO 27701等)。歡迎具有CAP/LDTS或ISO 15189臨床實驗室經驗或品質管理經驗的求職者投遞。
This position primarily assists the quality team in integrating, implementing, maintaining, and continuously improving quality management systems to ensure that company services, products, and processes comply with relevant legal and regulatory requirements (such as CAP, LDTS, ISO 27001, ISO 27701, ISO 13485, etc.). Candidates with experience in CAP/LDTS or GLP laboratory settings or ISO 13485 medical device quality management are welcome to apply.

〔Job Responsibility〕
主要職責如下：
The main responsibilities are as follows:
(1.) 負責或協助公司品質系統的整合、推行與維護之作業，例如矯正預防、變更管制、供應商管理、抱怨處理、管理審查等品質活動，並協助品質系統的持續改善活動以符合相關法令法規與客戶之要求。
Assist in integrating, implementing, and maintaining the company's quality systems, including activities such as corrective and preventive actions, change control, supplier management, complaint handling, management review, and other quality activities. Also, support continuous improvement activities of the quality system to meet relevant legal and regulatory requirements as well as customer demands.
(2.) 對臨床實驗室出現的品質事件進行跟蹤與處理，並參與品質相關文件與程序的撰寫、審閱以及核准，與跨部門單位合作進行品質相關專案的推進並提供品質或法令法規相關意見。
Track and handle quality events occurring in the clinical laboratory. Participate in the drafting, review, and approval of quality-related documents and procedure. Collaborate with cross-functional departments to advance quality-related projects and provide opinions on quality or regulatory matters.
(3.) 作為能力試驗單位的聯絡窗口，協助/負責能力試驗與替代性評估的規劃，以及跨部門單位合作進行能力試驗與替代性評估的選擇、訂購、收送件以及紀錄與報告彙整。
Act as the primary liaison for proficiency testing providers, responsible for the planning and coordination of proficiency testing and alternative assessment activities, including cross-functional collaboration on program selection, ordering, sample logistics (receipt and shipment), and the compilation of associated records and reports.
(4.) 負責或協助公司內外部稽核活動，包括主管機關、驗證單位、國內外客戶之定期或不定期稽核，並進行缺失改善回覆與追蹤。
Responsible for or assisting in internal and external audit activities of the company, including audits by regulatory authorities, certification bodies, domestic and international clients on a regular or irregular basis. Conduct follow-up and tracking corrective actions for identified deficiencies.
(5.) 參與LDTS檢測品項認證準備與申請作業，與跨部門和法規團隊合作確保檢測品項之相關文件與流程符合內部規範以及法令法規與客戶之要求。
Participate in activities related to preparation and submission of LDTS certification, collaborating with cross-departmental and regulatory affair teams to ensure that the related documentation and operational processes of products and service comply with internal standards as well as legal and regulatory requirements, and meet customer demands.
(6.) 負責、積極主動且善於溝通，並能進行跨部門溝通協助解決問題。
Responsible, proactive, and proficient in communication, with the ability to engage in cross-departmental communication to assist in problem-solving.
(7.) 其他主管交辦事項。
Other tasks assigned by supervisors.

Note: 錄取者的職稱將取決於其工作經驗以及面談結果。
The job title for the position will depend on the candidate's work experience and interview performance