Senior Quality Engineer: Medical Devices & Process

Boston Scientific; George Town; On-site; MYR 120,000 - 180,000; Full time

Job summary

Boston Scientific in Malaysia seeks a Quality Engineer to ensure product and process quality in a regulated medical devices setting. You will identify nonconformities, perform risk assessments, and drive CAPA investigations across manufacturing and testing activities.

The role requires a Bachelor’s in Engineering and at least 5 years of experience in quality engineering, process validation, and regulatory compliance, with strong analytical skills and proficiency in Excel and Minitab.

Qualifications

• Bachelor’s Degree in Engineering, Technology, or a related Science discipline.
• Minimum 5 years in a regulated industry, preferably medical devices.
• Experience in quality engineering, process validation, and quality system compliance.

Responsibilities

• Identify and resolve complex exceptions to work assignments.
• Disposi­tion of non-conforming materials and drive CAPA investigations.
• Read and interpret technical drawings, procedures, and protocols.
• Support validation activities and develop validation protocols and reports.

Skills

ISO 13485 knowledge

Root Cause Analysis

CAPA / NCEP / FMEI investigations

Six Sigma / Lean

Excel / Minitab (statistical analysis)

Cross-functional collaboration

Education

Bachelor's Degree in Engineering or related Science

Tools

Minitab

Excel

Job description

Boston Scientific in Malaysia seeks a Quality Engineer to ensure product and process quality in a regulated medical devices setting. You will identify nonconformities, perform risk assessments, and drive CAPA investigations across manufacturing and testing activities.

The role requires a Bachelor’s in Engineering and at least 5 years of experience in quality engineering, process validation, and regulatory compliance, with strong analytical skills and proficiency in Excel and Minitab.