Senior Quality Engineer - Medical Devices & Compliance

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. 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.