Senior Quality Engineer - Medical Device Validation

Boston Scientific; Penang; On-site; MYR 70,000 - 90,000; Full time

Job summary

A global medical device company is seeking a Quality Engineer in Penang, Malaysia, to develop and maintain quality engineering methodologies that meet regulatory requirements. Responsibilities include implementing process control systems, ensuring compliance with quality standards, and leading quality initiatives. Ideal candidates should hold a Bachelor's degree in Engineering or Science with at least 5 years of experience in a Quality environment, preferably in medical devices. Proficiency in Bahasa Malaysia and English is required.

Qualifications

• Minimum 5 years of working experience in a Quality environment.
• Conversant with validation techniques and associated regulatory requirements.
• Experience from a medical device background is a plus.

Responsibilities

• Identify and implement effective process control systems for product manufacturing.
• Ensure quality methodologies meet BSC, customer, and regulatory requirements.
• Develop testing methodologies and documentation for products.

Skills

Project management

Validation

Problem solving

Communication

People management

Education

Bachelor's degree in Engineering, Science, or related field

Job description

A global medical device company is seeking a Quality Engineer in Penang, Malaysia, to develop and maintain quality engineering methodologies that meet regulatory requirements. Responsibilities include implementing process control systems, ensuring compliance with quality standards, and leading quality initiatives. Ideal candidates should hold a Bachelor's degree in Engineering or Science with at least 5 years of experience in a Quality environment, preferably in medical devices. Proficiency in Bahasa Malaysia and English is required.