APAC Supplier Quality Leader

Insulet; Gelang Patah; On-site; MYR 80,000 - 120,000; Full time

Job summary

A leading healthcare company is seeking a Quality Manager to oversee manufacturing quality programs in Gelang Patah, Malaysia. The role focuses on establishing a quality management system, ensuring FDA compliance, and leading inspections. Ideal candidates will have a BS in engineering or a related field, with a minimum of 5 years in FDA regulated environments and a strong background in quality management methodologies. The company offers competitive compensation and a dynamic work environment.

Qualifications

• Minimum 5 years of experience in the FDA regulated environment.
• Experience in quality management in an FDA regulated industry.
• Knowledge of ISO programs and Quality principles using statistics.

Responsibilities

• Manage quality programs and ensure compliance with FDA regulations.
• Establish KPIs for quality performance and lead inspections.
• Develop training programs and improve manufacturing processes.

Skills

Six Sigma

Statistical Process Control

Verbal Communication

Technical Writing

Interpersonal Skills

Education

BS degree in engineering or science

Tools

Process management software

Statistical data analysis tools

Job description

A leading healthcare company is seeking a Quality Manager to oversee manufacturing quality programs in Gelang Patah, Malaysia. The role focuses on establishing a quality management system, ensuring FDA compliance, and leading inspections. Ideal candidates will have a BS in engineering or a related field, with a minimum of 5 years in FDA regulated environments and a strong background in quality management methodologies. The company offers competitive compensation and a dynamic work environment.