Design Quality Senior Engineer

This position is responsible for quality control of changes on existing products that are producing in Nextern VN.
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.
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).
Create Quality Process Control for new product.
Create required documentation that relevant to product specifications and requirements (Process flow, control plan, inspection criteria, etc.)
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.
Return Material Authorization (Intra Nextern)
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.
Perform Test Method Validation for testing, inspection, measurement process.
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.
Non- Conforming Material Processing (Manufacturing, Supplier, & Engineering Change Causes)
Engineering change process validation and monitoring.
Product and Process Qualification & Validation.
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
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.
Equipment (Functional Test, Assembly Fixtures, Manufacturing Aids, etc.) Selection & Qualification.

Experience in FMEA as a leader.
Have experience on technical field of plastic molding, metal stamping, PCBA is preferred.
Engineering degree or higher (Prefer candidate have experience in medical device)
Experience in product qualification and process creation and qualification.
Minimum 4 years’ experience in process quality management and 2 years’ experience in Engineering or design.
Experience in Test Method Validation execute.
Excellent in excel (especially VBA), word, excel and PowerPoint.
Can use measurement equipment such as Vision Measuring Machine (VMM), Coordinate Measuring Machine (CMM),…
Very good in presentation and communication, especially in English.
Knowledge about improving concept (Kaizen, 6 sigma, lean manufacturing, etc.).
Experience in Solving problem (follow 8D).
Expert in process capability and control, Minitab.
Leadership behavior is preferred.
ISO9001:2015 certification is mandatory (ISO13485 certification is preferred)
Language: must be highly fluent in English (written & verbal).

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Cập nhật gần nhất lúc: 2025-09-16 13:20:02