Global Head of Medical Device Quality & Compliance

Bactiguard; Seberang Perai; On-site; MYR 150,000 - 200,000; Full time

Job summary

A leading medical device company in Penang is seeking a Quality Senior Manager/Director to lead the Quality Management System and ensure compliance with global regulations. The ideal candidate should have over 20 years of experience in Medical Device Quality Assurance and a strong track record in senior leadership roles. Responsibilities include overseeing quality processes, leading a high-performing team, and collaborating with various departments. This position offers a dynamic work environment and contributes to the development of safe, effective products.

Qualifications

• 20+ years of experience in Medical Device Quality Assurance.
• At least 5 years in senior leadership roles.
• Strong track record with global regulatory authorities.

Responsibilities

• Develop a clear quality vision and strategic roadmap.
• Lead and mentor a high-performing Quality team.
• Maintain and enhance the QMS in compliance with regulations.
• Oversee product lifecycle quality activities and quality metrics.

Skills

Quality Management Systems

Regulatory Compliance

Leadership

Supplier Quality Management

Statistical Process Control

Root Cause Analysis

Education

Bachelor’s or Master’s degree in engineering or life sciences

Professional certifications such as CQE, CQA

Job description

A leading medical device company in Penang is seeking a Quality Senior Manager/Director to lead the Quality Management System and ensure compliance with global regulations. The ideal candidate should have over 20 years of experience in Medical Device Quality Assurance and a strong track record in senior leadership roles. Responsibilities include overseeing quality processes, leading a high-performing team, and collaborating with various departments. This position offers a dynamic work environment and contributes to the development of safe, effective products.