Job Overview

Take responsibility for product quality in NPI phase, and ensure all the new product and process development compliant with LeanPD procedure to ensure a robust development process and flawless transfer from NPI to Mass Production.

Job Requirements

• Monitoring the whole NPI activities ensure it compliant with product development process and quality management system.
• Be responsible for NPI projects gate quality compliance and NPI projects launch on time.
• Be responsible for quality deliverables in NPI phase including Control Plan, QIP, TMV, DHR, DHF audits, etc.
• Ensure NPI engineering sample quality performance, establish inspection method and training NPI QC and operators.
• Lead the quality issue during NPI phase such as NCs and customer complaint
• Interface with Engineering and Operations to ensure safe launch of new products are in accordance with approved data.
• Conduct line audits periodically and support on external audit on NPI section.
• Lead customer quality audit in NPI phase.
• Be responsible for related data trending analysis, and prepare of quality reports periodically.
• Perform any other task as defined in related quality procedure or assigned by manager.

What your background should look like

1. Minimum BS degree in engineering or science.
2. 8 years working experience with at least 5 years’ experience as a NPI Quality Engineer.
3. Product development experience is a must.
4. Strong knowledge in Engineering, familiar with SPC, FMEA, DOE, DMAIC. 6-sigma green belt is preferred.
5. Thorough knowledge in quality tools, such as Control Plan, QIP, Gauge R&R, Risk Assessment, 8D report.
6. Experience with Minitab or similar statistical analysis software.
7. Work experience in Medical manufacturing with DV, PV knowledge is highly preferred.
8. Fluent in oral English

Competencies