QA / Quality Assurance Manager - medical device / surgical equipment / instrument manufacturing

Job level Senior
Location
Within Hong Kong
Employment type Permanent
Benefits 13-month pay, Discretionary bonus, Guaranteed bonus, Medical plan
Industry Manufacturing - Others
Job function Engineering > Others
Manufacturing > Quality Assurance / Control
Quality Control / Quality Assurance > Quality Control & Assurance
Published On 15/09/2018
Manufacturer of medical device, surgical device & instruments with office in Hong Kong and factory in Dongguan China – mainly export to North America and European markets  -  core items are precision electro-surgical pencil, surgical knife, surgical sealer, wound dressing, skin stapler, cardiac insulation pad, oxygen filter etc -  we are looking for a QA MANAGER  – with details as follows : 
 
  • Degree holder or above, preferably in Quality Assurance, Engineering, Manufacturing; or related disciplines.
  • 8 to 10 years or above solid experience in QA/QC; of which preferably over 3 years in managerial level
  • Solid experience in mechanical, electronic or medical manufacturing 
  • Familiar with ISO 9001:2000, ROHS and other regulatory systems
  • Good knowledge of Directive 93142 EEC, CMDCAS is definitely an advantage
  • Business level of English and Mandarin
  • Direct report to Plant Director
  • Manage the laboratory, quality control and document control team of the factory
  • Maintain good relationship with certify bodies both in HK and China 
  • Formulate and manage all functions of Quality Assurance and Quality Control program, policies and procedures.
  • Manage and maintain QA processes and ensure proper documentation in place.
  • Work closely with line managers to ensure workflows and products are complying with customers and international standards.
  • Organize customer audits, certification process, failure analysis, and corrective action plan. 
  • Conduct and organize seminar or training: for staffs, company representatives, and/or vendors to fulfill the quality requirements. 
  • Frequent Dongguan trip or station Dongguan
 
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