Senior Quality Engineer - Process Validation & CAPA

Boston Scientific Gruppe; Malaysia; On-site; MYR 60,000 - 180,000; Full time

Job summary

Boston Scientific Gruppe is seeking a Quality Engineer to lead investigations and drive quality improvements within a regulated medical device environment. The role requires strong analytical skills and experience with CAPA, validation, and risk management.

You will work cross-functionally with engineering, manufacturing, and QA teams to ensure compliance with quality systems and regulatory requirements, while supporting new product transfers and complaint handling processes.

Qualifications

• Minimum 5 years of experience in a regulated industry, preferably medical devices.
• Experience in quality engineering, process validation, and quality system compliance.
• Strong analytical and problem-solving skills.

Responsibilities

• Identify and resolve complex quality issues in work assignments.
• Summarize analyses and draw conclusions from test results.
• Read and interpret technical drawings, procedures, and protocols.
• Identify and disposition manufacturing defects and nonconforming material.
• Make decisions related to product quality with authority to disposition non-conforming product.
• Participate in customer complaints investigations and document findings.
• Provide training on software-related complaints handling (GCS2).
• Drive continual improvements in product and process quality.
• Support CAPA, NCEP, and Failure Mode Investigations.
• Evaluate new equipment/processes and assist in product transfers.
• Maintain awareness of ISO 13485, QMSR, and BSEN 14971 standards.
• Review and develop process validation protocols and reports.

Skills

Quality engineering

Root Cause Analysis

Analytical thinking

Cross-functional collaboration

Statistical analysis

CAPA investigations

Lean Six Sigma

Communication skills

Education

Bachelor’s Degree in Engineering/Technology or related Science

Tools

Excel

Minitab

Job description

Boston Scientific Gruppe is seeking a Quality Engineer to lead investigations and drive quality improvements within a regulated medical device environment. The role requires strong analytical skills and experience with CAPA, validation, and risk management.

You will work cross-functionally with engineering, manufacturing, and QA teams to ensure compliance with quality systems and regulatory requirements, while supporting new product transfers and complaint handling processes.