Quality Engineer III: Process & Quality Improvement Leader

Boston Scientific; Penang; On-site; MYR 70,000 - 120,000; Full time

Job summary

Boston Scientific in Penang, Malaysia is seeking an experienced Quality Engineer to lead quality improvements across manufacturing and test processes. You will analyze data, support CAPA investigations, and ensure compliance with QSR, ISO, and medical device regulatory requirements while guiding cross-functional teams.

You will review validation protocols, participate in new product transfers, and drive Six Sigma and Lean initiatives to prevent defects and enhance product quality.

Qualifications

• Bachelor's degree or higher in engineering.
• Minimum 6 years of experience in Operations Quality, medical device industry preferred.
• Strong knowledge of quality systems, regulatory requirements, and quality engineering principles.
• Experience in regulated manufacturing environments.
• Strong analytical and decision-making skills; able to resolve complex quality issues.

Responsibilities

• Identifies and resolves complex exceptions to work assignments.
• Summarizes, analyses, draws conclusions from test results or process findings.
• Read and interpret technical drawings, procedures, and protocols.
• Identify manufacturing defects and disposition non-conforming material; assist in root-cause analysis and corrective actions.
• Make decisions related to product quality, including disposition of non-conforming product.

Skills

Problem solving

Root cause analysis

CAPA

Quality management

Data analysis

Six Sigma/Lean

Regulatory knowledge

Communication

Team mentoring

Cross-functional collaboration

Education

Bachelor's degree or higher in Engineering

Job description

Boston Scientific in Penang, Malaysia is seeking an experienced Quality Engineer to lead quality improvements across manufacturing and test processes. You will analyze data, support CAPA investigations, and ensure compliance with QSR, ISO, and medical device regulatory requirements while guiding cross-functional teams.

You will review validation protocols, participate in new product transfers, and drive Six Sigma and Lean initiatives to prevent defects and enhance product quality.