Responsibilities:

• 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.

Requirement:

• 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.