Posted on 2021-11-22

QC Manager / Assistant Manager / Engineer

Emerging Viral Diagnostics (HK) Limited

Job Responsibility:

-       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.

 

Requirements:

-       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.

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More job information
Salary
  • 11,000 - 20,000 / month
Benefits
  • 5-day week
  • Dental plan
  • Medical plan
Job Function
Location
  • Tsimshatsui
Industry
Employment Term
  • Permanent
  • Full-time
Experience
    N/A