- ISO 900X Standards
- Quality Assurance
- Quality Control
QA MANAGER/Quality Assurance Manager - medical device/electronic manufacturing
Location: Within Hong Kong, China
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 - is 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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|Career Level||Senior (6-10 years)|
|Language||English, Mandarin (Putonghua)|