Senior Quality Engineer

BOSTON SCIENTIFIC MEDICAL DEVICE (MALAYSIA) SDN. BHD.; Batu Kawan; On-site; MYR 180,000 - 280,000; Full time

Job summary

Boston Scientific Medical Device Malaysia Sdn. Bhd. seeks an experienced Quality Engineer to uphold patient safety and product quality across daily QA activities.

You will interpret technical drawings, guide non-conformances to resolution, and support CAPA/validation initiatives while ensuring compliance with regulatory standards. Role requires 9+ years in operations quality within the medical device sector, cross-functional collaboration, and strong problem-solving skills.

Qualifications

• Bachelor's Degree in Engineering required.
• Minimum 9 years of experience in Operations Quality; medical device industry preferred.
• Strong grasp of quality operations fundamentals, including risk assessment and data analysis for root cause identification.
• Skilled in using standard problem-solving tools and communicating findings clearly.
• Experience in cross-functional management.
• Experience in product transfer is an advantage.

Responsibilities

• Demonstrate strong commitment to the Quality Policy, focusing on patient safety and product quality, through sound daily quality practices and maintenance of an effective quality system.
• Identify manufacturing defects (e.g., scrap, nonconforming material, customer complaints), support root cause identification, and guide corrective/preventive actions.
• Participate in customer complaint investigations within area of responsibility, documenting findings in GCS2 analysis reports.
• Serve as a trainer for complaint-handling software (GCS2) as needed.
• Support execution and investigation of CAPAs, NCEP, and Failure Mode Investigations.
• Promote high standards of QA engineering discipline and best practices.
• Act as go-to expert on QSR and ISO/MDD standards, escalating critical decisions to the Quality Engineering Manager/Site QA Director as needed.
• Apply strong expertise in validation engineering and regulatory requirements.
• Review and approve test/validation data to establish technical specifications for new or modified products/processes.
• Champion continuous improvement and quality initiatives from vendor selection through to customer satisfaction.
• Provide technical guidance to Quality Engineers, Associate Quality Engineers, and technicians/inspection staff.
• Collaborate with EHS to identify environmental impacts and set related goals/targets.
• Liaise with suppliers, other engineering teams, and customers as needed.
• Be familiar with internal audit processes.

Skills

Quality engineering

Risk assessment

Data analysis

Root cause analysis

Problem solving

Cross-functional collaboration

Validation

Regulatory compliance

Education

Bachelor's Degree in Engineering

Tools

GCS2

Job description

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

About the Role
Demonstrate strong commitment to the Quality Policy, with a focus on patient safety and product quality, through sound daily quality practices and maintenance of an effective quality system. Ensure compliance with all relevant quality regulations, and where applicable, guide direct reports to stay current with training requirements and regulatory compliance.

Apply appropriate problem-solving techniques to provide sound Engineering and Quality Assurance recommendations

Read and interpret technical drawings, procedures, and protocols

Hold independent authority to make product quality decisions, including disposition of non-conforming products

Identify manufacturing defects (e.g., scrap, nonconforming material, customer complaints), support root cause identification, and guide corrective/preventative actions

Participate in customer complaint investigations within area of responsibility, documenting findings in GCS2 analysis reports

Serve as a trainer for complaint-handling software (GCS2) as needed

Support execution and investigation of CAPAs, NCEP, and Failure Mode Investigations

Promote high standards of QA engineering discipline and best practices

Act as a go-to expert on QSR and ISO/MDD standards, escalating critical decisions to the Quality Engineering Manager/Site QA Director as needed

Apply strong expertise in validation engineering and regulatory requirements

Review and approve test/validation data to establish technical specifications for new or modified products/processes

Champion continuous improvement and quality initiatives from vendor selection through to customer satisfaction

Provide technical guidance to Quality Engineers, Associate Quality Engineers, and technicians/inspection staff

Collaborate with EHS to identify environmental impacts and set related goals/targets

Liaise with suppliers, other engineering teams, and customers as needed

Be familiar with internal audit processes

Bachelor's Degree in Engineering

Minimum 9 years of experience in Operations Quality; medical device industry experience preferred

Strong grasp of quality operations fundamentals, including risk assessment and data analysis for root cause identification

Skilled in using standard problem-solving tools and communicating findings clearly

Experience in cross-functional management

Experience in product transfer is an advantage

Pharmaceuticals, Biotechnology & Medical Devices 1,001-5,000 employees

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.

Your application will include the following questions:

• Which of the following statements best describes your right to work in Malaysia?
• How many years' experience do you have as a Quality Engineer?
• Which of the following types of qualifications do you have?