Quality Engineer II – RI/FG, CAPA & Process Improvement

Boston Scientific Gruppe; Malaysia; On-site; MYR 89,000 - 156,000; Full time

Job summary

Boston Scientific Gruppe in Malaysia seeks a Quality Engineer with at least 3 years of experience in a regulated manufacturing environment. The role focuses on identifying defects, ensuring product releases meet quality standards, and supporting CAPA and root cause analyses.

You will collaborate across Manufacturing, Engineering, Materials, and Quality teams to drive improvements. The ideal candidate has IQA and IQA/OutQA experience, equipment validation know-how, and strong problem-solving

Qualifications

• Undergraduate Degree in Science, Material Engineering, or a related discipline.
• Minimum 3 years of experience in Quality Engineering within a regulated manufacturing environment.
• Experience in Incoming Quality Assurance (IQA) and Outgoing Quality Inspection.
• Experience in equipment qualification and test method validation.
• Experience supporting material issue management and product release activities.

Responsibilities

• Identify and resolve complex exceptions to work assignments.
• Dispositions non-conforming material and supports root cause analysis.
• Review and release product in compliance with quality/regulatory requirements.
• Participate in CAPA, NCEP, and Failure Mode Investigations as needed.
• Provide guidance to junior QA staff and collaborate with Manufacturing, Engineering, and Quality stakeholders.
• Drive continuous improvement using Six Sigma and Lean principles.

Skills

Stakeholder management

IQA experience

FG QA

Release accountability

Equipment validation

Root cause analysis

Statistical analysis

Six Sigma

SAP knowledge

Cross-functional collaboration

Education

Bachelors in Science

Material Engineering

Quality Engineering background

Tools

SAP knowledge

Job description

Boston Scientific Gruppe in Malaysia seeks a Quality Engineer with at least 3 years of experience in a regulated manufacturing environment. The role focuses on identifying defects, ensuring product releases meet quality standards, and supporting CAPA and root cause analyses.

You will collaborate across Manufacturing, Engineering, Materials, and Quality teams to drive improvements. The ideal candidate has IQA and IQA/OutQA experience, equipment validation know-how, and strong problem-solving