IPQC Senior Engineer

Mô tả Công việc
Position Summary:
Nextern, an US based innovator in developing and manufacturing class II & III electro-mechanical medical devices is seeking a IPQC Senior Engineer for its Binh Duong, Vietnam location. Join an organization with a passion for commercializing smart, effective and patient centric medical device solutions.
Our IPQC Senior Engineer is a key organizational part of the operations management and continuation engineering teams. Specifically, In Process Quality Control (IPQC) is key to establishing and sustaining our business culture of continuous improvement by leveraging data to improve processes, eliminate waste, and compel the business and our customers to take action. We enable business growth by developing quality professionals in the areas of predictive engineering, lean six sigma, root cause analysis, issue investigation, and process control.
This position is responsible for quality control of all incoming inspection, product manufacturing assembly lines and production processes between Nextern and key customers in the Integrated Systems business. The IPQC Senior Engineer will be a key part of operating global requirements of our day-to-day performance in engineering, manufacturing, and supply chain, while balancing accountability between both companies to achieve exceptional product quality performance in compliance with government and regulatory agency requirements and directives.
Job Description:
The following processes are key to IPQC performance within Nextern and between Nextern and our key customer collaborators. This role must be proficient at achieving outcomes on time, with high quality documentation content, and cross-functional team awareness/support (internal & external).
1. Manage CAPA (Corrective Action Preventive Action) on molding production line.
2. Evaluate the Process Qualification & Validation.
3. Manage all activities of quality inspectors.
4. Make sure production lines follow manufacturing procedures and production operators are trained when working on lines.
5. Process Control & Yield/Trend Monitoring of other products.
6. Return Material Authorization (Customers to Nextern).
7. Failure Analysis of Returned Products (Out of Box & Fielded).
8. Manage all non-conforming on the production lines
9. Create required documentations that are relevant to product specifications and requirements when manager assign (Process flow, control plan, inspection criteria, etc.)
10. Manage inspection of out-going shipment