Senior Quality Systems Lead, Global Medical Devices

Cochlear; Kuala Lumpur; On-site; MYR 120,000 - 170,000; Full time

Job summary

Cochlear is hiring a Senior Quality System Specialist to strengthen our Quality Management System across global operations. You will ensure compliance with international standards, lead internal audits, drive CAPA/NCR resolution, and prepare the organization for external regulatory audits.

This role suits a quality professional passionate about compliance, problem‑solving, and continuous improvement in a regulated environment.

Qualifications

• Bachelor's degree in a relevant engineering/science field.
• 4–7 years in medical device or related industry.
• Strong experience with QMS in regulated industries (medical devices preferred).
• Hands‑on CAPA, NCR, root cause analysis, internal audits, and continuous improvement.
• Familiarity with ISO 13485, MDSAP, FDA 21 CFR 820, EU MDR; knowledge of Malaysian MDA guidelines.
• Ability to interpret standards, perform gap assessments, and implement governance frameworks.
• Data literacy with KPI tracking, metrics, and management reporting.
• Excellent communication and stakeholder facilitation; ability to lead training and governance forums.
• Project management across cross‑functional teams (PMP a plus).

Responsibilities

• Govern QMS governance, drive improvement, and partner with stakeholders on audits and document changes.
• Support CAPA/NCR processes to drive timely, data‑driven resolutions; coach owners.
• Lead continuous improvement initiatives and measure QMS health with KPIs and metrics.
• Support regulatory and tender audits; contribute to MDSAP readiness and audits.
• Follow quality procedures; participate in safety, audits, and cross‑functional teamwork.

Skills

QMS in regulated industries

CAPA/NCR

Root cause analysis

Internal audits

Data literacy & KPI tracking

Management reporting

Stakeholder facilitation

Training & governance facilitation

Project management across cross‑func.

Education

Bachelor's degree in Biomedical Engineering

Job description

Cochlear is hiring a Senior Quality System Specialist to strengthen our Quality Management System across global operations. You will ensure compliance with international standards, lead internal audits, drive CAPA/NCR resolution, and prepare the organization for external regulatory audits.

This role suits a quality professional passionate about compliance, problem‑solving, and continuous improvement in a regulated environment.