1.Supplier quality evaluation and management
2.Ensure the suitability of Infrastructure maintenance and preventive maintenance of production machines and equipment
3.Ensure that maintenance of infrastructure and production machines and equipment are adequately performed and 4.maintenance records are appropriate and suitable
5.Material Handling and Customer Property Control
6.Handling of customer complaints and customer feedback
7.CAPA management, verify and validate Corrective And Preventive Action (CAPA) taken and on-time closure monitoring
8.Establish and maintain test equipment Calibration Program
9.Process and complaints quality problem handling & process improvement
10.Lead Quality Improvement Team
11.Identify existing and potential causes of nonconforming product, and processes
12.Identify actions needed to correct and prevent recurrence
13.Assist QA Manager to ensure compliance to ISO9001:2001, ISO13485:2003, 21 CFR 820, and CE standards
14.Assist QA Manager to promote awareness of our QMS, Customer and Regulatory requirements and in the daily work live up to our four core values
15.Ensure good adherence to Supplier Quality Agreement with Ambu AS per QP2001
Key Requirements (职位要求):
1.High & Excellent English speaking & writing level
2.Good knowledge in ISO standards and 21 CFR 820
3.Lead auditor
4.Qualified IQA
5.Minimum 2 years QC experience
6.Team player and stable personality
7.Microbiologist background is preferred
8.Good analytical skill
9.Good knowledge in validation requirement