Senior Quality Engineer - Medical Devices & Regulatory

Cochlear Malaysia SDN BHD. (Malaysia); Kuala Lumpur; On-site; MYR 120,000 - 180,000; Full time

Job summary

Cochlear Malaysia SDN BHD. (Malaysia) is seeking a Senior Quality Engineer to ensure regulatory compliance across the Quality Management System and products, partnering with stakeholders to meet FDA 21 CFR Part 820 and EN ISO 13485 and related standards.

The role supports Production and Engineering in identifying, evaluating and solving quality issues, implementing corrective actions, and driving Quality System improvements with risk-based methods.

Qualifications

• Strong knowledge of ISO 9001, ISO 13485, FDA QSR (21 CFR Part 820), MDSAP, and EU MDR.
• Experience in NCR handling and corrective actions.
• Proficient in documentation and procedural writing.
• Auditing skills for internal and external audits.

Responsibilities

• Ensure regulatory compliance across QMS and products.
• Identify, evaluate, contain, investigate, and apply corrective actions for Class 3 devices.
• Support NCR process with problem-solving meetings and Concession implementation.
• Support First Time Quality and audit activities.
• Conduct internal audits and manage external audits.
• Review QMS documents and propose changes.
• Initiate and implement improvements to QMS processes.
• Produce KPIs and data analysis on NCRs and reports.

Skills

Regulatory compliance

Quality management systems

Audit management

Documentation

Tools

FMEA

Root cause analysis

Statistical process control

Job description

Cochlear Malaysia SDN BHD. (Malaysia) is seeking a Senior Quality Engineer to ensure regulatory compliance across the Quality Management System and products, partnering with stakeholders to meet FDA 21 CFR Part 820 and EN ISO 13485 and related standards.

The role supports Production and Engineering in identifying, evaluating and solving quality issues, implementing corrective actions, and driving Quality System improvements with risk-based methods.