招聘人数：1-2人
到岗时间：不限
年龄要求：不限
婚况要求：婚姻状况
语言要求：
英语
Tasks and responsibilities:
- Follow up quality standard with suppliers
- Manage the process control of purchase or sub-contract product according to specific procedure and make sure they can match the product assembly.
- Identify the Non-conformity and manage them with the related suppliers.
- Ensure implementation and follow-up on corrective / preventive actions and requests for improvement
- Work closely with R&D department for testing and control
- Organize the flow of return product if there are.
- Organize and maintain the integration of quality area.
- Organize the rework
- Establish, implement, maintain and ensure the continuous improvement of the quality policy and the quality system in accordance with the applicable standards (ISO 9001, ISO 13485...).
- Ensure management and filing of all quality related company data.
- Authorize product release and register products for sale.
- Analyse quality costs.
- Manage third party audits (ISO13485, FDA, etc.), internal audits and supplier audits.
- Participate in complaint reviews and project reviews.
- Provide advice to all departments regarding any quality related issue.
- Ensure good contact with clients for any quality-related issues, in collaboration with relevant departments.
- Ensure that company employees are given training on the quality system.
- Organise and prepare data for Management Reviews.
- Implement risk management activities and supplier process validations.
- Authority to stop production in case of serious non-conformity, in agreement with the Management.
- Authority to waive or refuse deviations in consultation with relevant departments.
- Ensure that processes needed for the quality management system are established implemented and maintained
- Report to top management on the performance of the quality management system and any need for improvement
- Depending on the need of the company, the employee would be required for other tasks.
Job Requirements:
- Chinese native (English speaking fluent).
- Experience in Electro Medical device
- Know how in implementation and maintaining ISO 13485 & ISO 9001
- Experience in metal, Plastic, electronic board (PCBA) Inspection
- Know how in regulatory affairs and registration process of Medical device
- Experience in IQC, PQC and FQC for mechanical parts, sub-assemblies, PCB, flex, appearance part, plastic parts,..)
- Performed Internal/external Audit
- Maintain the QMS
- Driving force for continuous improvement of process & products
- Technical background (electronic, mechanical, assembly)
- Experience of 3-5 years at least as Quality manager.
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