Senior Quality Engineer - FG/RI & Process Improvement

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

Job summary

Boston Scientific is seeking a Quality Engineer to identify and resolve complex quality issues in a regulated manufacturing setting. You will analyze test results, interpret drawings and protocols, and make decisions on disposition of non-conforming material to ensure compliant product releases.

You will support CAPAs, NCEP, FMEA, and transfer activities while driving ongoing product and process improvements through data-driven methods and cross-functional collaboration.

Qualifications

• Minimum 5 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

• Identifies and resolves complex exceptions to work assignments.
• Summarizes, analyzes, draws conclusions and makes appropriate decisions from test results or other process findings.
• Read and interpret technical drawings, procedures, and protocols.
• Identify manufacturing defects and disposition non-conforming material with corrective actions.
• Dispositions non-conforming product and participates in CAPAs, NCEP and FMEAs as needed.
• Provide technical guidance to Associates and Inspectors and support transfer of new products.
• Promote Six Sigma, statistical analysis and Lean principles to investigate and improve quality.

Skills

Stakeholder management

Communication skills

Root cause analysis

Statistical analysis

Lean Six Sigma

Quality assurance

Team collaboration

Education

Undergraduate Degree in Science/Materials

Tools

SAP

Job description

Boston Scientific is seeking a Quality Engineer to identify and resolve complex quality issues in a regulated manufacturing setting. You will analyze test results, interpret drawings and protocols, and make decisions on disposition of non-conforming material to ensure compliant product releases.

You will support CAPAs, NCEP, FMEA, and transfer activities while driving ongoing product and process improvements through data-driven methods and cross-functional collaboration.