Req ID: 135519
Remote Position: No
Region: Asia
Country: Malaysia
State/Province: Johor
City: Senai

**Summary**

Senior Quality Manager - New Production Introduction (NPI) Focus

**Detailed Description**

+ **Quality Planning & Strategy:** Lead the design and deployment of Quality Management Systems (QMS) processes and tools to ensure NPI objectives and customer requirements are met.
+ **DFx & Technical Readiness:** Drive **Design for Excellence (DFx)** reviews and oversight on validation strategies (IQ,OQ,PQ) to ensure seamless product transitions from design to mass production.
+ **Launch Readiness:** Manage launch readiness assessments, Monthly Operations Reviews, and Customer Satisfaction Surveys to ensure operational excellence at the HealthTech sites.
+ **Regulatory Oversight:** Ensure site-wide conformance to international regulations and customer certifications (e.g., **ISO 13485, ANSI/ESD** ).
+ **Perform...