The NISI Group, a robotic surgery start-up, is looking for high-caliber candidates to make significant contributions in a revolutionary robotic surgical project.
jobsDB Ref. JHK100003004782798
- Assist in the development and implementation of QA systems
- Coordinate and assist in the resolution of deviations, out-of-specification (OOS) or any other quality events as directed by QA management
- Hands-on experience in the approval of raw materials, finished products testing and writing of standard operating procedures
Candidates are expected to fulfill most of the following requirements:
- Bachelor degree or above in Biomedical Engineering\Industrial Engineering or science related subjects
- At least 2 years of medical device experience in Quality Assurance field
- Conversant in medical device regulatory regulations an advantage
- Ability to develop, implement and review Qualification Protocols
- Able to conduct audits as per ISO & GMP’s requirements
- Knowledge of risk analysis principles, equipment and process validation principles as described under FDA 21CFR Part 820 and International regulations
- Knowledge of cGMP\ISO13485 regulations strongly preferred
- Familiar with internal audit is an advantage
- Language proficiency in English and Cantonese, and preferably in Putonghua
- Good command of MS Word and Excel
- Good typing speed in Simplified Chinese.
Salary will be commensurate with qualifications and experience. To apply, please click Apply Now to submit your resume, including personal particulars, employment history, current and expected salary, contact phone number and availability.
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