Quality Engineer

The Quality Engineer has responsibility for the assurance of the Quality System at the Shanghai facility; adherence to local regulatory requirements, cGMP and for compliance of the Quality System.

Key Responsibilities:

• Follow all Quality System procedures related to this job, which can affect the quality of products or services provided to our customers
• Maintain the Quality System activities in compliance with ISO13485 and local regulatory requirements
• Provide QA support for Shanghai manufacturing line, including NCR dispositioning and DHR releases
• Perform Internal Audits
• Provide support for External Audits
• Perform Supplier Audits
• Support to Customer Complaint process

Key Requirements:

• Bachelor's degree (B.A.) from four-year college or university in a clinical/medical/biological engineering related discipline; and two to four years related experience in Medical Device Company and/or training; or equivalent combination of education and experience