Quality Engineer

BOSTON SCIENTIFIC MEDICAL DEVICE (MALAYSIA) SDN. BHD.; Batu Kawan; On-site; MYR 60,000 - 100,000; Full time

Job summary

Boston Scientific Medical Device (Malaysia) Sdn. Bhd. is seeking an experienced Quality Engineer to develop, implement, and maintain quality engineering practices across product development, manufacturing, and supplier interfaces.

You will drive compliance with regulatory requirements, lead validation activities, and collaborate with cross-functional teams to ensure patient safety and product quality. The role emphasizes problem solving, process optimization, and effective communication in a

Qualifications

• Bachelor's degree in engineering, science, or related field.
• 2–8 years of relevant experience in a Quality environment.
• Skills: project management, validation, problem-solving, communication, people management.
• Proficiency in Bahasa Malaysia and English.
• Medical device background is an advantage.
• Experience in project/product transfer is an advantage.

Responsibilities

• Identify and implement effective process control systems to support product development, qualification, and ongoing manufacturing.
• Ensure quality engineering methods and systems meet BSC, customer, and regulatory requirements.
• Create and revise departmental procedures.
• Act as a leader or team member in supporting quality practices and decisions.
• Apply systematic problem-solving methods to identify, prioritize, and resolve quality issues.
• Support development and execution of streamlined business systems to address quality concerns.
• Develop testing/inspection methodologies and documentation for new and existing products.
• Generate test protocols/reports and execute qualification/validation testing.
• Review and develop validation protocols and reports, supporting other departments during validation activities.
• Liaise with other engineering departments, customers, and suppliers on quality-related matters.
• Apply knowledge of validation techniques and relevant regulatory requirements.
• Demonstrate strong commitment to patient safety and product quality by complying with Quality Policy and procedures.

Skills

Project management

Validation

Problem solving

Communication

People management

Education

Bachelor's Degree in Engineering/Science or related field

Job description

BOSTON SCIENTIFIC MEDICAL DEVICE (MALAYSIA) SDN. BHD. 4.2 View all jobs

About the Role

Develop, establish, and maintain quality engineering methodologies, systems, and practices that meet Boston Scientific (BSC), customer, and regulatory requirements. Act as a Quality representative to drive awareness and communication of quality initiatives across departmental, site, and corporate levels, providing focused quality engineering support for new product development, operations, or system/services functions.

Key Responsibilities

• Identify and implement effective process control systems to support product development, qualification, and ongoing manufacturing
• Ensure quality engineering methods and systems meet BSC, customer, and regulatory requirements
• Create and revise departmental procedures
• Act as a leader or team member in supporting quality practices and decisions
• Apply systematic problem-solving methods to identify, prioritize, and resolve quality issues
• Support development and execution of streamlined business systems to address quality concerns
• Develop testing/inspection methodologies and documentation for new and existing products
• Generate test protocols/reports and execute qualification/validation testing
• Review and develop validation protocols and reports, supporting other departments during validation activities
• Liaise with other engineering departments, customers, and suppliers on quality-related matters
• Apply knowledge of validation techniques and relevant regulatory requirements
• Demonstrate strong commitment to patient safety and product quality by complying with Quality Policy and procedures

Additional Responsibilities (For Those Supervising Others)

• Ensure appropriate resources (personnel, tools, etc.) are maintained to support Quality System compliance
• Establish and promote a work environment aligned with the Quality Policy and Quality System

Job Requirements

• Bachelor's Degree in Engineering, Science, or related field
• 2–8 years of relevant experience in a Quality environment
• Skills required: project management, validation, problem-solving, communication, people management
• Proficiency in Bahasa Malaysia and English
• Medical device background is an advantage
• Experience in project/product transfer is an advantage

Your work can make a difference.

Imagine knowing that what you do every day contributes to technologies that help improve millions of lives.

For more than 45 years, Boston Scientific has been transforming lives through innovative medical technologies

And Penang is part of that global story.

Our Penang site became first manufacturing facility in Asia, with the plant completed in 2017. Today, we supports manufacturing and APAC regional distribution operations, connecting the work of our local teams with patients & healthcare systems around the world.

Here you can learn, collaborate, innovate & grow while contributing to a purpose bigger than any one role.

Your work can make a difference.

Imagine knowing that what you do every day contributes to technologies that help improve millions of lives.

For more than 45 years, Boston Scientific has been transforming lives through innovative medical technologies

And Penang is part of that global story.

Our Penang site became first manufacturing facility in Asia, with the plant completed in 2017. Today, we supports manufacturing and APAC regional distribution operations, connecting the work of our local teams with patients & healthcare systems around the world.

Here you can learn, collaborate, innovate & grow while contributing to a purpose bigger than any one role.