Senior Quality Engineer – FG & Process Improvement

Boston Scientific Gruppe; Penang; On-site; MYR 90,000 - 150,000; Full time

Job summary

Boston Scientific in Penang, Malaysia, is hiring a Quality Engineer to identify defects, perform root cause analysis, and support CAPA investigations in a regulated manufacturing environment.

You will own incoming and outgoing quality inspections, participate in product release decisions, and drive continuous improvements in processes and quality systems across cross-functional teams. A strong analytical mindset and data-driven approach are essential.

Qualifications

• Undergraduate degree in Science, Material Engineering, or related discipline.
• Minimum 5 years of experience in Quality Engineering within a regulated manufacturing environment.
• Experience in Incoming Quality Assurance (IQA) and Outgoing Quality Inspection (OQA).
• Experience in equipment qualification and test method validation.

Responsibilities

• Identifies and resolves complex manufacturing exceptions.
• Owns dispositioning of non-conforming material and supports in identifying root causes.
• Documents investigation findings in analysis reports and CAPA records.
• Drives continuous improvements in product and process quality across the site.
• Reviews and develops process validation protocols and reports; supports validation activities.

Skills

Stakeholder management

Quality inspections

Root cause analysis

CAPA

Data analysis

Problem solving

Cross-functional collaboration

Decision making

Process validation

Analytical thinking

Education

Undergraduate degree in Science, Material Engineering, or related discipline

Tools

SAP

Job description

Boston Scientific in Penang, Malaysia, is hiring a Quality Engineer to identify defects, perform root cause analysis, and support CAPA investigations in a regulated manufacturing environment.

You will own incoming and outgoing quality inspections, participate in product release decisions, and drive continuous improvements in processes and quality systems across cross-functional teams. A strong analytical mindset and data-driven approach are essential.