Senior Quality Engineer – Medical Devices & CAPA

Boston Scientific Gruppe; Malaysia; On-site; MYR 80,000 - 140,000; Full time

Job summary

Boston Scientific is seeking a Quality Engineer to ensure product quality and regulatory compliance across the manufacturing lifecycle. You will interpret technical drawings, support CAPAs, and lead problem-solving with robust data analysis.

The role requires a Bachelor's in Engineering and 4–5 years in a regulated environment, preferably medical devices. You will collaborate across functions to drive continuous improvement and uphold ISO 13485 standards.

Qualifications

• Bachelor's Degree in Engineering, Technology, or related Science.
• Minimum 4 to 5 years in a regulated industry, preferably medical devices.
• Experience reviewing nonconforming event risk assessments and investigations.
• Strong understanding of quality systems, regulatory requirements, and validation processes.
• Strong analytical mindset with proven problem-solving capability.

Responsibilities

• Selects appropriate problem-solving techniques and provides QA and engineering recommendations.
• Read and interpret technical drawings, procedures, and protocols.
• Decides on product quality disposition including non-conforming material.
• Identify manufacturing defects and support CAPAs and corrective actions.
• Participates in Customer Complaints investigations.
• Reviews and approves validation data to establish specs for new or modified products and processes.
• Champion continuous improvement and QA discipline within the department.

Skills

Root Cause Analysis

Analytical thinking

Cross-functional collaboration

Problem solving

Communication skills

Education

Bachelor's Degree in Engineering or related Science

Tools

Minitab

Excel

Job description

Boston Scientific is seeking a Quality Engineer to ensure product quality and regulatory compliance across the manufacturing lifecycle. You will interpret technical drawings, support CAPAs, and lead problem-solving with robust data analysis.

The role requires a Bachelor's in Engineering and 4–5 years in a regulated environment, preferably medical devices. You will collaborate across functions to drive continuous improvement and uphold ISO 13485 standards.