Global QMS Lead: Compliance, CAPA & Continuous Improvement

Cochlear; Kuala Lumpur; On-site; MYR 80,000 - 110,000; Full time

Job summary

A leading medical device company in Kuala Lumpur is seeking a Senior Quality System Specialist to enhance their Quality Management System. The role involves ensuring compliance with international standards, conducting internal audits, and driving quality improvements. Applicants should possess 5-7 years experience in the medical device industry, with strong skills in CAPA, NCR, and data analysis. Join a collaborative team making a meaningful impact in global medical technology.

Benefits

Competitive compensation

Professional development opportunities

Collaborative work environment

Qualifications

• Minimum of 5-7 years experience within medical device industry or relevant industry.
• Strong experience with QMS in regulated industries, preferably medical devices.
• Hands-on expertise in CAPA, NCR, root cause analysis, and internal audits.
• Familiarity with international standards like ISO 13485 and FDA guidelines.

Responsibilities

• Ensure compliance with international standards for the Quality Management System.
• Conduct internal audits and lead data-led CAPA/NCR resolution.
• Project manage quality improvement initiatives across functions.
• Support regulatory and internal audits to improve the Quality Management System.

Skills

QMS in regulated industries

CAPA

NCR

root cause analysis

internal audits

continuous improvement

data literacy

excellent communication

project management

Education

Bachelor’s Degree in Biomedical Engineering, Mechanical Engineering, Electrical/Electronic Engineering, Pharmaceutical Science, Manufacturing / Production Engineering

Job description

A leading medical device company in Kuala Lumpur is seeking a Senior Quality System Specialist to enhance their Quality Management System. The role involves ensuring compliance with international standards, conducting internal audits, and driving quality improvements. Applicants should possess 5-7 years experience in the medical device industry, with strong skills in CAPA, NCR, and data analysis. Join a collaborative team making a meaningful impact in global medical technology.