Quality Engineer II: FG/RI Process & Compliance

Boston Scientific Gruppe; Penang; On-site; MYR 60,000 - 100,000; Full time

Job summary

Boston Scientific Gruppe in Penang, Malaysia, is seeking a Quality Engineer to drive product and process quality in a regulated manufacturing environment. You will apply Six Sigma and data-driven approaches to resolve complex quality issues and ensure compliant product releases.

Responsibilities include defect investigations, CAPAs, IQA/OQA support, and collaboration with Manufacturing, Engineering and Suppliers.

Qualifications

• Undergraduate degree in Science, Material Engineering, or a related discipline.
• Minimum 3 years of quality engineering experience in a regulated manufacturing environment.
• Experience in IQA and Outgoing Quality Inspection.
• Experience supporting material issue management and product release activities.

Responsibilities

• Identify and resolve manufacturing process defects by dispositioning non-conforming material.
• Lead investigations of CAPAs, NCEP, and Failure Mode Investigations.
• Document investigation findings in analysis reports.
• Review and develop process validation protocols and reports.
• Provide technical guidance to QA staff and collaborate with cross-functional teams.
• Assist in supplier and internal audits and ensure compliance with quality standards.
• Support product release decisions and ensure released products meet regulatory requirements.

Skills

Stakeholder management

Communication skills

Problem solving

Root cause analysis

Analytical thinking

Cross-functional collaboration

Data-driven decision making

Six Sigma

Lean principles

Quality improvement

Education

Bachelor's degree in Science/Materials Engineering

Tools

SAP

Job description

Boston Scientific Gruppe in Penang, Malaysia, is seeking a Quality Engineer to drive product and process quality in a regulated manufacturing environment. You will apply Six Sigma and data-driven approaches to resolve complex quality issues and ensure compliant product releases.

Responsibilities include defect investigations, CAPAs, IQA/OQA support, and collaboration with Manufacturing, Engineering and Suppliers.