IPQC Senior Engineer

Job Description

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 Engineer will be a key part of operationalizing 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).

2. Evaluate the Process Qualification & Validation of new products.

3. Weekly monitor and report the yield of products. Daily analyze the defects on production line.

4. Manage quality inspectors to make sure the production lines are good 5S and follow the procedures.

5. Manage IPQC of all products (In Process Quality Control & Pre-Shipment Inspection). Retain all shipment records and send them to the customer if required.

6. Handle customer complaints and Return Material Authorization (Customers to Nextern).

7. Non-Conforming Material Processing (Manufacturing, Supplier, & Engineering Change Causes)

8. Create required documentations that are relevant to the product, processes and requirements from superior.

9. Manage all DHR (Device history records).

10. Implement internal audit regularly.

Job Requirement

1.       Bachelor’s degree or higher (Prefer candidate have experience in medical device).

2.       Minimum 5 years’ experience in process quality management and 2 years in Senior quality Engineer level.

3.       Good in excel (especially VBA), word and PowerPoint.

4.       Influence in English conversation and writing.

5.       Good presentation and communication, especially in English.

6.       Leadership behavior is preferred.

7.       Knowledge about improving concepts (Kaizen, 6 sigma, lean manufacturing, etc.) is preferable.

8.       Knowledge about the clean room is preferable.