Senior Quality Engineer, Medical Devices

Boston Scientific Medical Device (Malaysia) Sdn. Bhd.; Penang; On-site; MYR 70,000 - 100,000; Full time

Job summary

Boston Scientific Medical Device (Malaysia) Sdn. Bhd. is seeking a dedicated Quality Engineer to monitor and improve product quality, interpret regulatory requirements, and lead investigations into nonconforming materials.

This role involves CAPA execution, process validation, and close collaboration with site QA teams. Strong analytical skills and knowledge of ISO 13485 are essential. The incumbent will drive improvements across manufacturing processes, support environmental, health and safety

Qualifications

• Strong knowledge of ISO 13485 and quality systems.
• Experience with CAPA, NCEP and Failure Mode Investigations.
• Ability to interpret validation protocols and regulatory requirements.
• Proven problem-solving skills and root-cause analysis.

Responsibilities

• Identify and resolve complex quality exceptions.
• Review and develop process validation protocols and reports.
• Support validation activities and cross-functional teams.
• Participate in customer complaints investigations and root-cause analysis.
• Promote best industry practices and drive quality improvements.

Skills

ISO 13485 knowledge

Regulatory compliance

CAPA & FMEA

Root Cause Analysis

Quality assurance

Education

Bachelor's degree in Engineering/Technology/Science

Job description

Boston Scientific Medical Device (Malaysia) Sdn. Bhd. is seeking a dedicated Quality Engineer to monitor and improve product quality, interpret regulatory requirements, and lead investigations into nonconforming materials.

This role involves CAPA execution, process validation, and close collaboration with site QA teams. Strong analytical skills and knowledge of ISO 13485 are essential. The incumbent will drive improvements across manufacturing processes, support environmental, health and safety