Senior Quality Leader - Malaysia Operations

Intuitive; Penang; On-site; MYR 180,000 - 240,000; Full time

Job summary

Intuitive is seeking a Director of Quality for Malaysia Operations in Penang to lead quality systems across the site and ensure compliance with international medical regulations. You will oversee IQC, MRB, PMC, FQI, DHR and Quality Engineering, driving site strategies and continuous improvement.

You will develop strategies, manage budgets, and collaborate with local and global teams to ensure high-quality manufacturing and regulatory excellence.

Qualifications

• Education: Engineering in electronics, biomedical, industrial or related field.
• Desirable: Six Sigma, MBA, Lead Auditor certification.
• Fluent English; German fluency highly desirable.
• System tools: Office, SAP; knowledge of statistical tools and drawings.

Responsibilities

• Lead quality operations and quality engineering for Malaysia Penang site.
• Ensure compliance with ISO 13485 and medical regulations.
• Develop site and regional quality strategies aligned with company goals.
• Oversee IQC, MRB, PMC, FQI, DHR and quality engineering functions.
• Monitor quality metrics and drive continuous improvement across manufacturing.

Skills

Quality leadership

Regulatory compliance

Data analysis

Leadership

Education

Engineering degree (electronics/biomedical/industrial)

Six Sigma certification desirable

MBA desirable

Certified Lead Auditor desirable

Tools

Office Suite

SAP

MSA / Statistical tools

Technical drawings

Job description

Intuitive is seeking a Director of Quality for Malaysia Operations in Penang to lead quality systems across the site and ensure compliance with international medical regulations. You will oversee IQC, MRB, PMC, FQI, DHR and Quality Engineering, driving site strategies and continuous improvement.

You will develop strategies, manage budgets, and collaborate with local and global teams to ensure high-quality manufacturing and regulatory excellence.