Senior Quality Engineer – Medical Devices, Regulatory & QMS

Cochlear; Kuala Lumpur; In loco; MYR 180.000 - 240.000; Tempo pieno

Descrizione del lavoro

Cochlear Malaysia is seeking a Senior Quality Engineer to ensure regulatory compliance across the Quality Management System and products, partnering with stakeholders to meet FDA QSR, ISO 13485, EU MDR, and MDSAP requirements. The role includes guiding production, engineering teams and training across the organization.

The position emphasizes leading internal and external audits, managing NCR/CAPA processes, and implementing risk-based Manufacturing Quality Plans, with a strong focus on accurate

Competenze

• Comprehensive knowledge of ISO 9001, ISO 13485, FDA QSR 21 CFR Part 820, MDSAP, and EU MDR.
• Proficient in NCRs, CAPA, RCA, FMEA and SPC for quality improvements.

Mansioni

• Ensure regulatory compliance across QMS and products with stakeholders.
• Identify, investigate and implement corrective actions for Class 3 devices.
• Support NCR process with problem-solving meetings and concessions.
• Drive internal and external audits and maintain QA documentation.
• Develop Manufacturing Quality Plans with MQP and risk-based approaches.

Conoscenze

Regulatory frameworks

FMEA & RCA

Quality documentation

Auditing

Stakeholder management

Excel / Power BI

Formazione

Bachelor's degree in Electrical/Mechanical Engineering

Strumenti

MES

ERP

QMS platforms

Descrizione del lavoro

Cochlear Malaysia is seeking a Senior Quality Engineer to ensure regulatory compliance across the Quality Management System and products, partnering with stakeholders to meet FDA QSR, ISO 13485, EU MDR, and MDSAP requirements. The role includes guiding production, engineering teams and training across the organization.

The position emphasizes leading internal and external audits, managing NCR/CAPA processes, and implementing risk-based Manufacturing Quality Plans, with a strong focus on accurate