About the job:

This role is responsible for ensuring timely and effective implementation of all company’s policies, procedures, and Quality Assurance (QA) related activities across Hong Kong (HK) and Taiwan (TW). This role needs to closely work with HK and TW stakeholders and regional/divisional QA team to support local Quality Assurance Specialist (QMS) activity to ensure the compliance to Corporate, ISO 13485 and HK and TW regulatory requirement.

What you will be doing:

• Manage the QMS in HK and TW and ensure its implementation and effectiveness.
• Ensure compliance to corporate, ISO13485, TW MDGDP requirements and any other local regulation pertaining to quality management system.
• Maintain the certification for ISO 13485 in HK and TW MDGDP.
• Act as the quality document controller, and support SOP revision and periodic review.
• Lead the risk management process for HK and TW.
• Manage the quality aspect of suppliers in HK and TW, including 3PL and distributors.
• Participate in all audits and inspections (regulatory, corporate, internal, external), including provision of CAPA response, where required.
• Assist in investigation of quality-related issues through collaboration with other departments.
• Handle product complaints through internal system, adverse event reporting to local authority, product hold, product field action coordination, and any other post mark market surveillance activities.
• Provide the Regional QA with regular updates on Quality activities highlights and KPI.
• Suggest proactive recommendations and solutions to RAQA team and other departments to improve quality, efficiency and to meet regulatory and company requirements.
• Collaborate with HKTW RAQA team and build relationship with other departments, including sharing of quality knowledge and information.
• Work closely with HK QA on QMS activities and provide oversight on post market surveillance activities in HK.
• Perform other QA duties as directed by Senior RAQA manager.

Who are we looking for:

• Bachelor’s degree in healthcare/medical/science/engineering/pharmacy or related major.
• A good knowledge of ISO13485, Taiwan MDGDP, and Medical device Act.
• Rich quality experiences in the healthcare industry (e.g., multinational pharmaceutical or medical device corporation).
• Minimum 8 years experience in Medical Device, preferably in the commercial/distribution environment.
• Certified internal auditor for ISO13485 or other internal auditor qualification.
• HK QA experience is a plus.

NOTE: Please attach an English version of your CV when applying for this role.

職位簡介：

該職位負責確保及時有效地實施公司在香港和臺灣的所有政策、程序和品質保證 (QA) 相關活動。該職位需要與香港和臺灣利益相關部門以及區域/事業體品質保證團隊密切合作，以支持當地品質保證專家 (QMS) 活動，確保符合公司、ISO 13485 以及香港和臺灣的法規監管要求。

工作內容：

• 管理香港和臺灣的品質管制體系並確保其實施和有效性。
• 確保符合公司、ISO13485、臺灣 MDGDP 要求以及任何其他與品質管制體系相關的當地法規。
• 維護臺灣 MDGDP 與香港 ISO 13485 認證。
• 擔任品質文檔控制員，並支援 SOP 修訂和定期審查。
• 領導香港和臺灣的風險管理流程。
• 管理香港和臺灣供應商的品質問題，包括協力廠商物流和分銷商。
• 參與所有稽核和檢查（法規監管、公司、內部、外部），包括在必要時提供 CAPA 回應。
• 通過與其他部門合作協助調查與品質相關的問題。
• 通過內部系統處理產品投訴、向當地主管機關報告不良事件、產品保留、產品現場行動協調以及任何其他上市後市場監督活動。
• 定期向區域 QA 提供有關品質活動重點和 KPI 的更新。
• 向 RAQA 團隊和其他部門提出積極建議和解決方案，以提高品質、效率並滿足法規監管和公司要求。
• 與香港台灣RAQA 團隊合作並與其他部門建立關係，包括品質知識和資訊。
• 與香港 QA 密切合作開展 QMS 活動，並監督香港的上市後監督活動。
• 根據資深RAQA 經理的指示執行其他 QA 職責。

我們正在尋找：

• 具醫療保健/醫學/科學/工程/藥學或相關專業的學士學位。
• 熟悉 ISO13485、臺灣 MDGDP 和醫療器材管理法。
• 在醫療保健行業擁有豐富的品質經驗（例如跨國製藥或醫療器材公司）。
• 至少 8 年醫療器材領域經驗，在商業/經銷環境中較佳。
• 獲得 ISO13485 或其他內部稽核員資格認證的內部稽核員。
• 具香港 QA 經驗者優先。

注意：申請此職位時請附上英文版簡歷。