Hong Kong Job Openings
TR at CUHK
Quality Engineer - Medical Device/ Robotics (Ref: MRC2024-036)
Sha Tin
FULL TIME & CONTRACT
September 19, 2024
Multi-Scale Medical Robotics Center Limited (MRC) was established by the Faculty of Medicine and the Faculty of Engineering of the Chinese University of Hong Kong in collaboration with ETH Zürich, Imperial College London, Johns Hopkins University and the University of Hong Kong. MRC focusing on technological innovation with a strong emphasis on clinical translation and direct patient benefits, serves as a synergistic platform for clinicians, engineers and researchers from local and overseas universities to work together and forge new ways to translate biomedical engineering research innovations into medical practices.
Job Responsibilities
- Support company goals and objectives, policies, and procedures in compliance with quality systems, and all other external regulatory requirements for which product is distributed for human trial.
- Provides quality engineering support to new product development, along with support for product transfer and human trial.
- Ensure accurate project schedules are maintained and communicated.
- Support other quality functions which may include supplier development and management, quality training initiatives
- Present data analysis and trend information to management and other groups as required.
- Support internal/external/corporate audits
- Works collaboratively with Operations and R&D project teams to develop and implement appropriate risk management, qualification, verification, and validation plans.
- Support Document Control initiatives and consult on continuous improvement activities involving the document control program. Assist with e QMS initiative.
- Manage activities and procedures associated with the Device Master Record (DMR) and Device History File (DHF). Support all activities with the batch records/device history record (DHR)
- Assist with maintaining the Risk Management Files and participate in Risk Analysis of changes. Lead efforts with completing a full risk assessment of the receiving, kitting, and shipping of products (PFMEA/Risk Analysis)
- Assist with maintaining and management the Software Lifecycle requirements per IEC 62304
- Background in mechanical, electronical or software design and analysis is preferred.
- The employee may be asked to perform other tasks related to his/her competence.
- Bachelor’s degree in Mechanical, Electronics or computer science or related major is required
- Strong project management skills as well as an ability to multi-task.
- Ability to write reports, business correspondence and procedure.
- Ability to respond internally to common inquires, regulatory agencies, or members of the business community.
- Ability to effectively present information to top management, groups and /or boards of directors
- A minimum of five years of quality engineering experience, preferred.
- A minimum of three years of experience in the medical device preferred.
- Thorough knowledge of ISO 13485:2016
- Preferred experience with IEC 62304 Software Lifecycle requirements
- Excellent attention to detail and communication skills (written and oral)
- Good analytical and statistical problem-solving skills / tools.
Salary will be commensurate with qualifications and experience. Appointment will be made on a 1 or 2-year contract (with contract-end gratuity for a 2-year contract), renewable subject to good performance and mutual agreement. Please send your CV with last salary and your expected salary.
Job Types: Full-time, Contract
Benefits:
- Dental insurance
- Medical Insurance
- Monday to Friday
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