Senior Quality Engineer: Medical Device Regulatory & QMS

Cochlear; Kuala Lumpur; Presencial; MYR 120.000 - 180.000; Jornada completa

Descripción de la vacante

Cochlear Malaysia is seeking a Senior Quality Engineer to ensure regulatory compliance across the QMS and products, guiding stakeholders to meet ISO 13485, FDA QSR, and EU MDR requirements. You will support NCR processes, audits, and QMS improvements across Manufacturing and Logistics.

The role emphasizes training, process validation, and robust documentation to sustain high-quality implantable medical devices and services for Cochlear’s global operations in Malaysia.

Formación

• Minimum Bachelor’s degree in Electrical/Mechanical Engineering or equivalent.
• At least 6 years of experience in Quality or manufacturing operations in regulated Medical Device industry, including senior role.
• Experience with Quality Management tools, data analysis, metrics, reporting, and statistical methods.

Responsabilidades

• Ensure regulatory compliance across the QMS and products by partnering with stakeholders and guiding to meet FDA QSR 21 CFR Part 820, ISO 13485, EU MDR, MDSAP.
• Identify, investigate, and apply corrective actions for Class 3 Active Implantable Medical Devices across Manufacturing and Logistics.
• Support NCR process with regular problem-solving meetings and concessions implementation guidance.
• Support First Time Quality, Fast Response and Morning Market meetings.
• Conduct internal audits and support external audits.
• Review QMS documents for proposed changes or product related changes.
• Identify and implement improvements to QMS processes and produce KPI data analyses.

Conocimientos

Regulatory knowledge

Auditing

Quality documentation

Risk management

Data analysis

Stakeholder management

NPI collaboration

Educación

Bachelor's degree in Electrical/Mechanical Engineering

Herramientas

Excel

Power BI

MES

ERP

QMS platforms

Descripción del empleo

Cochlear Malaysia is seeking a Senior Quality Engineer to ensure regulatory compliance across the QMS and products, guiding stakeholders to meet ISO 13485, FDA QSR, and EU MDR requirements. You will support NCR processes, audits, and QMS improvements across Manufacturing and Logistics.

The role emphasizes training, process validation, and robust documentation to sustain high-quality implantable medical devices and services for Cochlear’s global operations in Malaysia.