Senior Quality Systems Lead – CAPA, Audits & QMS

Cochlear Malaysia Sdn Bhd; Kuala Lumpur; On-site; MYR 120,000 - 180,000; Full time

Benefits offered by this job

Professional development opportunities

Competitive compensation

Global exposure

Job summary

Cochlear Malaysia Sdn Bhd in Kuala Lumpur is seeking a Senior Quality System Specialist to strengthen and continuously improve our Quality Management System across global operations. You will ensure compliance with international standards, lead internal audits and drive CAPA/NCR resolution.

This role demands a data-led mindset, robust problem-solving, and the ability to partner with cross-functional teams to support regulatory audits and continuous improvement initiatives.

Qualifications

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical/Electronic Engineering, Pharmaceutical Science, or related.
• 4–7 years in medical device or regulated industry.
• Strong knowledge of QMS in regulated industries (medical devices preferred).

Responsibilities

• Govern QMS governance and drive continuous improvement.
• Lead CAPA/NCR processes and train owners in data-driven decisions.
• Capture and analyse quality metrics for monthly reporting.
• Support regulatory audits and readiness across global locations.
• Coordinate cross-functional quality improvement projects.

Skills

CAPA/NCR

Root cause analysis

Internal audits

Data literacy

Project management

Cross-functional collaboration

Education

Bachelor's degree in Biomedical/Mechanical/Electrical/Electronic Engineering or related

Job description

Cochlear Malaysia Sdn Bhd in Kuala Lumpur is seeking a Senior Quality System Specialist to strengthen and continuously improve our Quality Management System across global operations. You will ensure compliance with international standards, lead internal audits and drive CAPA/NCR resolution.

This role demands a data-led mindset, robust problem-solving, and the ability to partner with cross-functional teams to support regulatory audits and continuous improvement initiatives.