Global Quality Senior Manager - NPI

Senior Quality Manager - New Production Introduction (NPI) Focus

Req ID:

Remote Position: No

Region: Asia

Country: Malaysia

State/Province: Johor

City: Senai

Responsibilities

• 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).
• Performance Monitoring:...