Quality Engineer – Regulatory & Manufacturing (Medical Devices)

C16 Cochlear Malaysia SDN BHD. (Malaysia); Kuala Lumpur; On-site; MYR 90,000 - 130,000; Full time

Job summary

Cochlear Malaysia SDN BHD. is seeking a motivated Quality Engineer to support regulatory compliance and manufacturing quality for Class III active implantable medical devices in Kuala Lumpur.

You will partner with Manufacturing, Engineering and cross‑functional teams to ensure QMS and products meet global regulatory requirements. The role emphasizes problem‑solving, continuous improvement, and robust documentation in a highly regulated medical device environment.

Qualifications

• Bachelor’s degree in Engineering or Science is required.
• Experience in regulatory frameworks (ISO 13485, FDA QSR, EU MDR) is preferred.
• Hands-on experience with NCR, CAPA, Concessions, and CAPA handling processes.

Responsibilities

• Ensure QMS and product regulatory compliance across the organization.
• Investigate non-conformances and implement corrective actions.
• Lead internal and supplier audits and support external audits.
• Develop and maintain procedural and technical documentation.
• Generate KPIs and data analysis on non-conformances and CAPA actions.

Skills

Regulatory compliance

NCR handling

CAPA handling

Risk-based problem solving

FMEA

Root cause analysis

Documentation

Internal auditor

Education

Bachelor’s degree in Engineering or Science

Tools

ISO 13485

FDA QSR (21 CFR Part 820)

Job description

Cochlear Malaysia SDN BHD. is seeking a motivated Quality Engineer to support regulatory compliance and manufacturing quality for Class III active implantable medical devices in Kuala Lumpur.

You will partner with Manufacturing, Engineering and cross‑functional teams to ensure QMS and products meet global regulatory requirements. The role emphasizes problem‑solving, continuous improvement, and robust documentation in a highly regulated medical device environment.