Senior QMS Lead — Medical Devices (CAPA & Audits)

C16 Cochlear Malaysia SDN BHD. (Malaysia); Kuala Lumpur; On-site; MYR 110,000 - 170,000; Full time

Benefits offered by this job

Competitive compensation

Professional development

Audit readiness & system excellence

Job summary

Cochlear Malaysia SDN BHD. is seeking a Senior Quality System Specialist to strengthen and improve our global QMS across operations. You will drive CAPA/NCR resolution, lead internal audits, and prepare the organization for external regulatory audits in a regulated medical device environment.

Qualified candidates have 4–7 years in medical devices, strong QMS experience, and expertise in problem-solving, data analytics, and cross‑functional collaboration to sustain continuous improvement.

Qualifications

• Bachelor’s Degree in Biomedical Engineering or related engineering/science field for regulated environments.
• Minimum 4–7 years in medical devices or a regulated industry.
• Strong experience with QMS in regulated industries (medical devices preferred).
• Hands‑on expertise in CAPA, NCR, root cause analysis, internal audits, and CI.

Responsibilities

• Governance & improvement of the Quality Management System; monitor performance against quality objectives.
• Drive CAPA/NCR processes with data-driven decision making and root cause analysis.
• Establish and maintain core QMS processes: change control, document management, standards management, training.
• Support regulatory audits and readiness; participate in internal and external audits and CI initiatives.

Skills

CAPA

NCR

Root cause analysis

Internal audits

Continuous improvement

KPI tracking

Data literacy

Education

Biomedical Engineering

Mechanical Engineering

Electrical/Electronic Engineering

Pharmaceutical Science

Manufacturing/Production Engineering

Job description

Cochlear Malaysia SDN BHD. is seeking a Senior Quality System Specialist to strengthen and improve our global QMS across operations. You will drive CAPA/NCR resolution, lead internal audits, and prepare the organization for external regulatory audits in a regulated medical device environment.

Qualified candidates have 4–7 years in medical devices, strong QMS experience, and expertise in problem-solving, data analytics, and cross‑functional collaboration to sustain continuous improvement.