Regional Quality Leader, Asia-Pacific & Compliance

BD Mexico; Kuala Lumpur; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading healthcare company is seeking a Quality Systems leader in Kuala Lumpur. This role involves ensuring quality process compliance, supporting post-market activities, and driving continuous improvement initiatives. The ideal candidate will have strong experience in regulatory compliance and project management, and will serve as the subject matter expert for ERP systems. This position requires excellent collaboration skills and the ability to manage various quality projects effectively.

Qualifications

• Experience in ISO 13485 and regulatory compliance is essential.
• Proven track record in quality management and process improvement.
• Strong analytical skills and experience in data analysis.

Responsibilities

• Support Management Representative for QMS processes.
• Lead quality compliance and post-market activities.
• Manage projects from initiation to closure.

Skills

Quality Systems Management

Regulatory Compliance

Data Analysis

Continuous Improvement

Leadership

Project Management

Team Collaboration

Education

Degree in Quality Management, Engineering or related field

Tools

ERP systems (SAP, JDE)

Quality tools and statistical methods

Job description

A leading healthcare company is seeking a Quality Systems leader in Kuala Lumpur. This role involves ensuring quality process compliance, supporting post-market activities, and driving continuous improvement initiatives. The ideal candidate will have strong experience in regulatory compliance and project management, and will serve as the subject matter expert for ERP systems. This position requires excellent collaboration skills and the ability to manage various quality projects effectively.