- Perform ISO13485 quality system start up project;
- Setup factory IQC / OQA / shopfloor quality procedures and standard to achieve market expectations;
- Carry out quality system internal audit in regular basis to meet ISO;
- Ensure regulatory compliance of products and manufacturing processes;
- Perform product quality reliability test & software test for medical equipment;
- Create & update quality standard & relevant procedures;
- Product failure analysis & motivate quality improvement from field users’ feedback;
- Supplier’s audit relating to key components;
- Perform ad-hoc duties when management required.
- Diploma or higher in Biomedical/Medical Engineering, Electronic Engineering or Electrical Engineering, Mechanical Engineering or related discipline
- Minimum 3 years working experience in medical device or medical equipment manufacturing industry;
- Experience in setup ISO13485, CE-IVD, ISO9001 quality system and related regulatory requirements;
- Familiar to quality tools, 8D report, Six Sigma, SPC, FMEA tools etc.
- Good computer skills including the ability to make use MS to do analyze data and presentation;
- Highly motivated, results oriented, self-driven personality and well communication skill;
- Based in Hong Kong and travel to China if needed;
- Well command in spoken and written English and Mandarin is much appreciated.
Interested candidates should apply in confidence with date of earliest availability, and current & expected salary by clicking Apply Now.
Personal data provided will be used for recruitment and related purposes only and strictly in accordance with the relevant Personal Data Policy for Employment. Applicants who are not contacted within 6 weeks may consider their application unsuccessful and the personal data collected will be destroyed in due course.