Regulatory Quality Engineer (Medical Devices)

Cochlear Malaysia Sdn Bhd; Kuala Lumpur; On-site; MYR 90,000 - 140,000; Full time

Job summary

Cochlear Malaysia Sdn Bhd is seeking a Quality Engineer (KL) to support regulatory compliance and manufacturing quality for Class III active implantable devices. You will partner with Manufacturing, Engineering and cross-functional teams to ensure the QMS and products meet global regulatory, customer and business needs.

This role suits a detail-oriented quality professional who enjoys problem-solving in a highly regulated medical device environment and wants to contribute to continuous

Qualifications

• Bachelor's degree in Engineering or Science is required.
• 2–5 years of experience in Quality or Manufacturing within regulated medical devices.
• Experience with NCR, CAPA and change control processes.
• Knowledge of ISO 9001, ISO 13485, FDA QSR, MDSAP and EU MDR.
• Strong data analysis and reporting skills; attention to detail.
• Internal auditor certification preferred; willingness to learn audits.
• Excellent written and spoken English is essential.

Responsibilities

• Ensure regulatory compliance across QMS and products with FDA 21 CFR Part 820 and ISO 13485.
• Assist in NCR investigations and CAPA for Class III devices across Manufacturing and Logistics.
• Identify improvements to maintain compliant, high-quality manufacturing and processes.
• Support internal and supplier audits and assist with external audits.
• Review and maintain QMS documents for proposed changes or product changes.
• Produce metrics and data analysis on non-conformances; deliver periodic reports.
• Collaborate with Process Engineering to design practical, risk-based quality plans.
• Deliver training on process changes and improvements to stakeholders.

Skills

Regulatory compliance

QMS knowledge

NCR/CAPA handling

Auditing (internal/external)

FMEA / risk analysis

Documentation skills

SPC / statistical methods

English proficiency

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in Engineering or Science

Tools

Non-conformance tracking

CAPA management

Audit management tools

Job description

Cochlear Malaysia Sdn Bhd is seeking a Quality Engineer (KL) to support regulatory compliance and manufacturing quality for Class III active implantable devices. You will partner with Manufacturing, Engineering and cross-functional teams to ensure the QMS and products meet global regulatory, customer and business needs.

This role suits a detail-oriented quality professional who enjoys problem-solving in a highly regulated medical device environment and wants to contribute to continuous