Quality Engineer, Medical Devices — Class III

Cochlear; Kuala Lumpur; On-site; MYR 70,000 - 100,000; Full time

Job summary

Cochlear Malaysia is seeking a Quality Engineer to support regulatory compliance and manufacturing quality for Class III active implantable devices. The role partners with Manufacturing, Engineering and cross-functional teams to ensure our QMS and products meet global regulatory, customer, and business requirements.

The position focuses on problem-solving, continuous improvement, and working in a highly regulated medical device environment.

Qualifications

• Working in a highly regulated Class III medical device environment with strict compliance requirements.
• Experience with Non-Conformance Reports (NCRs) and risk-based problem solving.
• Knowledge of quality tools (FMEA, root cause analysis, SPC) and documentation best practices.
• Auditing capability and familiarity with ISO 13485, ISO 9001, FDA QSR, MDSAP, EU MDR.

Responsibilities

• Ensure regulatory compliance across QMS and products per ISO 13485, FDA QSR, EU MDR.
• Identify, investigate and implement corrective actions for Class III devices across Manufacturing and Logistics.
• Lead internal and supplier audits and support external audits.
• Produce KPI metrics and data analysis on NCRs; deliver periodic reports.
• Deliver training on process changes and improvements; mentor stakeholders.

Skills

Regulated environment

NCR management

FMEA

Root cause analysis

SPC

Documentation

Internal auditing

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Science

Job description

Cochlear Malaysia is seeking a Quality Engineer to support regulatory compliance and manufacturing quality for Class III active implantable devices. The role partners with Manufacturing, Engineering and cross-functional teams to ensure our QMS and products meet global regulatory, customer, and business requirements.

The position focuses on problem-solving, continuous improvement, and working in a highly regulated medical device environment.