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Design Quality Senior Engineer

Nextern Vietnam Co.
Updated: 07/07/2025

Employment Information

Benefits

Laptop, Chế độ bảo hiểm, Du Lịch, Xe đưa đón, Chế độ thưởng, Chăm sóc sức khỏe, Đào tạo, Tăng lương, Công tác phí, Nghỉ phép năm, -Professional and Friendly Working Environment, chance to attend employee’s training and development programs - Premium healthcare Insurance (In Vietnam) & Business travel insurance - Company trip, New Year party, Team building - Occasion-based offerings: Birthday, New year, Mid-Autumn

Job requirement

This position is responsible for quality control of new products that are designed by Nextern US and running a trial in Nextern VN and control the quality of components that will be submitted to US site.

This position is responsible for quality control of changes on existing products that are producing in Nextern VN.

Job Description:

Activities and relevant KPI Targets: The following processes are key to Design quality Engineer 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. Product and Process Qualification & Validation.

2. Engineering change process validation and monitoring.

3. Equipment (Functional Test, Assembly Fixtures, Manufacturing Aids, etc.) Selection & Qualification.

4. Create Quality Process Control for new product.

5. Return Material Authorization (Intra Nextern)

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

7. Create required documentation that relevant to product specifications and requirements (Process flow, control plan, inspection criteria, etc.)

8. Perform Test Method Validation for testing, inspection, measurement process.

9. Partners with Product Development team on developing schedule, risk registers and actively supports business strategy. Ensures that solutions are successfully implemented by removing organizational or technical roadblocks.

10. Take lead the Product Development team to execute the need of each project deliverable and deliverable interdependencies and where in the Product Development Process cycle they need to be planned and completed

11. Working knowledge of project deliverables and ability to generate with no guidance. Understands the impact of decisions and needs of other functions. Able to exercise judgment to set direction for medium to high complexity projects.

12. Able to set directions for Risk Management activities on a project of medium complexity and execute required deliverables. Works independently to ensure Design Control deliverables are properly informed by RM and RM documentation is properly updated as a result of Design Control activities.

13. Capable of driving strategic business process improvement activities. Provides input to new project scope and can guide the business development team on strategic approach to quoting new projects.

Company Overview

Nextern Vietnam Co.

https://nextern.com Number of employees: 25-99

Nextern collaborates with innovators, clinicians, and companies to create, iterate, optimize, and manufacture best-in-class medical devices. We structure our... View more

Design Quality Senior Engineer

Nextern Vietnam Co.