Senior Quality Engineer, Medical Devices – QA Leader

Boston Scientific Medical Device (Malaysia) Sdn. Bhd.; Penang; Presencial; MYR 180.000 - 260.000; Jornada completa

Descripción de la vacante

Boston Scientific Medical Device (Malaysia) Sdn. Bhd. in Penang seeks an experienced QA Engineering leader to drive quality decisions, investigations and CAPA programs across cross-functional teams.

The role emphasizes adherence to ISO 13485, QSR, and MDD requirements, with strong problem-solving and guidance to engineers, technicians, and inspectors. The ideal candidate will have a minimum of 9 years in Operations Quality within medical devices, and hands-on ISO 13485 experience, contributing

Formación

• Bachelor’s degree in Engineering, Science, or related field.
• Experience leading quality investigations (CAPA, NCEP, nonconformance).
• Strong knowledge of validation, risk assessment, data analysis, QSR, and ISO/MDD requirements.
• Ability to guide engineers, technicians and inspectors across cross-functional teams.

Responsabilidades

• Selects techniques for problem solving and provides QA recommendations.
• Read and interpret technical drawings, procedures, and protocols.
• Has authority to disposition non-conforming product and determine quality decisions.
• Identify defects, root causes and corrective actions; support product release criteria.
• Lead customer complaints investigations and document findings.
• Provide training on software-related complaints handling (GCS2) as required.
• Support CAPAs, NCEP, failure investigations and related analyses.
• Guide others in QA discipline and promote best industry practices.
• Collaborate with internal teams and suppliers; participate in audits and reviews.
• Review and approve validation data to establish specifications for new/modified processes.

Conocimientos

Leadership

Problem solving

Cross-functional collaboration

Technical guidance

Educación

Bachelor’s degree in Engineering or Science

Descripción del empleo

Boston Scientific Medical Device (Malaysia) Sdn. Bhd. in Penang seeks an experienced QA Engineering leader to drive quality decisions, investigations and CAPA programs across cross-functional teams.

The role emphasizes adherence to ISO 13485, QSR, and MDD requirements, with strong problem-solving and guidance to engineers, technicians, and inspectors. The ideal candidate will have a minimum of 9 years in Operations Quality within medical devices, and hands-on ISO 13485 experience, contributing