ANKH 機能再生-痛症健康集團is a leading and rapidly growing enterprise in the Pain Relief and Healthcare sector in Hong Kong. We are seeking top talents to join our team. We offer competitive salaries, opportunities for career development, a fast track for promotions, and a merit-based system for our top talents and partners.
Our mission is to be the most competitive enterprise. Every family has our health services and products. Bringing a more healthy and happy life for everyone.
Responsibilities:
- Responsible for the maintaining QMS13485 quality management system for medical devices of the company, which included but not limited in R&D, Engineering Build (EVT), Design Verification, Pilot Build(PVT) and Mass Production process
- Provide strong product verification and process validation supports for devices, including testing plans on: electronics, mechanical, software, product cosmetics and process control
- Work with new product development team to develop and maintain the best quality management system and product validation process
- Maintain the QMS documentation system and internal audit activities
- Work with R&D Team to define Verification and Validation process and maintain and execute the V&V plan to make sure robustness/reliability of firmware design
- Supporting R&D Team on Product Safety, Compliance, Reliability and Quality Assurance plan and execution
- Conduct the Product Milestone Review Meeting on device safety, reliability, DFM, FMEA to make sure the timely design quality delivery
- Implement systematical 8D problem solving approach to find root cause and make correction plan for all the issues in in NPD and Production phase
- Define and Implement Design Verification Test with Software Testing Engineers in each EB build to evaluate robustness/reliability of firmware design
- Define with R&D Team the manufacturing and testing process of the sub-con factories
- Maintain the Lab Equipment and Calibration Plan
- Conducting the Supplier Evaluation Process with R&D and Supply Chain Team
Requirements:
- Bachelor degree in electromechanical engineering or related majors
- At least 5+ years’ experience in QMS13485 and IEC60601 related medical device development
- Good experience in product design verification and validation
- Previous industry experience in MCU-based electromechanical products is a PLUS
- Good knowledge of QMS 13485
- Good design verification and validation skills
- Good knowledge in testing system for MCU-peripheral interface (such as: power supply, sensor, heater and motor control etc.)
- Good knowledge 6-sigma and quality methodologies is a PLUS
- Good knowledge of SLDC, PEMS and Usability Test is a PLUS
- Good knowledge of design for manufacturability and testability is a PLUS
Good skill on reading, writing and oral English and Chinese (Cantonese and /or Mandarin) communication
- Be flexible for business traveling to Hong Kong and Mainland China
Benefits:
We offer competitive salary packages and fringe benefits to the right candidate. Interested parties please send a full resume with current and expected salary to the Human Resources Department by clicking 'APPLY NOW'.
For more information, please visit our website https://www.ankh.com.hk
Personal data collected will be used for recruitment purpose only.
職責:
- 負責維護公司醫療器材的QMS13485質量管理體系，包括但不限於研發、工程驗證（EVT）、設計驗證、試生產（PVT）和大量生產流程
- 為醫療器材提供強大的產品驗證和流程確認支持，包括電子、機械、軟體、產品外觀和流程控制方面的測試計畫
- 與新產品開發團隊合作，開發並維護最佳的質量管理系統和產品驗證流程
- 與研發團隊合作，定義驗證和確認流程，並維護和執行驗證和確認計劃，以確保韌體設計的穩健性和可靠性
- 支援研發團隊制定和執行產品安全、合規性、可靠性和質量保證計畫
- 主持產品里程碑評審會議，討論器械的安全性、可靠性、可製造性設計（DFM）和失效模式及影響分析（FMEA），以確保按時交付高質量的設計
- 實施系統的8D問題解決方法，找出根本原因並制定針對所有問題的糾正計畫。新產品開發和生產階段
- 與軟體測試工程師合作，在每個工程單元 (EB) 建置中定義並實施設計驗證測試，以評估韌體設計的穩健性和可靠性
要求:
- 至少 5 年以上符合 QMS13485 和 IEC60601 標準的醫療器材開發經驗
- 熟悉 MCU 週邊介面（例如：電源、感測器、加熱器和馬達控制等）的測試系統
- 良好的英語和中文（粵語和/或普通話）讀、寫、說能力
福利待遇:
我們為合適的應徵者提供具競爭力的薪酬待遇及福利。有意者請點擊「立即申請」，將個人完整履歷、現時薪酬及期望薪酬遞交至人力資源部。
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