Senior Quality Engineer, Medical Devices Compliance

Cochlear Limited; Kuala Lumpur; Hybrid; MYR 120,000 - 160,000; Full time

Job summary

Cochlear Limited in Kuala Lumpur is seeking a Senior Quality Engineer to ensure regulatory compliance across the Quality Management System (QMS) and products. You will partner with stakeholders to meet standards such as FDA 21 CFR Part 820, ISO 13485, EU MDR, and MDSAP.

You will support production and engineering teams, drive CAPA and NCR processes, and mentor other departments on quality requirements to deliver compliant medical devices for patients worldwide.

Qualifications

• Minimum 6 years of experience in Quality or manufacturing operations in regulated Medical Device industry (preferably Class 3).
• At least 4 years of experience in a Senior Quality Engineer role.
• Experience with NCRs, CAPA, concessions, and product acceptance processes.
• Strong documentation skills with procedural and technical writing experience.

Responsibilities

• Ensure regulatory compliance across QMS and products aligning with ISO 13485, FDA QSR, MDSAP, and EU MDR.
• Lead NCR investigations, CAPA actions and Concessions with cross-functional teams.
• Support audits (internal and external) and drive timely closure of findings.
• Develop and maintain Manufacturing Quality Plans (MQP) and support New Product Introduction and Validation teams.

Skills

Regulatory knowledge

NCR/CAPA management

Data analysis

Auditing

Stakeholder management

Education

Bachelor’s degree in Electrical / Mechanical Engineering or equivalent

Tools

MS Excel

Power BI

MES/ERP/QMS familiarity

Job description

Cochlear Limited in Kuala Lumpur is seeking a Senior Quality Engineer to ensure regulatory compliance across the Quality Management System (QMS) and products. You will partner with stakeholders to meet standards such as FDA 21 CFR Part 820, ISO 13485, EU MDR, and MDSAP.

You will support production and engineering teams, drive CAPA and NCR processes, and mentor other departments on quality requirements to deliver compliant medical devices for patients worldwide.