Senior Quality Engineer – FG/RI & CAPA Leader

Boston Scientific; Penang; Sur place; MYR 245 000 - 408 000; Plein temps

Résumé du poste

Boston Scientific Malaysia is seeking a Quality Engineer with 5+ years in a regulated manufacturing environment to identify defects, approve product releases, and drive continuous improvement across processes. You will lead IQA and OQ activities, validate equipment and test methods, perform risk assessments, and collaborate with cross-functional teams to ensure compliance with QSR/ISO standards.

Requires an undergraduate degree in Science or Materials Engineering; strong analytical,

Qualifications

• Undergraduate degree in Science, Material Engineering, or a 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.
• Experience in equipment qualification and test method validation.
• Experience supporting material issue management and product release activities.

Responsabilités

• Identifies manufacturing defects and disposition non-conforming material.
• Reviews investigations and supports CAPAs, NCEP, and failure investigations.
• Participates in customer complaints investigations for areas under control.
• Documents investigation findings in analysis reports (GCS2).
• Reviews and develops process validation protocols and reports; supports validation activities.
• Provides guidance to Associate Quality Engineer, Technician and Inspection staff.

Connaissances

Stakeholder management

Communication

Problem solving

Root cause analysis

Data-driven decisions

Statistical analysis

Cross-functional collaboration

Risk assessment

Nonconforming material investigation

SAP knowledge

Formation

Undergraduate degree in Science/Mater. Eng

Outils

SAP

Description du poste

Boston Scientific Malaysia is seeking a Quality Engineer with 5+ years in a regulated manufacturing environment to identify defects, approve product releases, and drive continuous improvement across processes. You will lead IQA and OQ activities, validate equipment and test methods, perform risk assessments, and collaborate with cross-functional teams to ensure compliance with QSR/ISO standards.

Requires an undergraduate degree in Science or Materials Engineering; strong analytical,