Senior Quality Engineer - Regulatory Compliance Leader

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

Job summary

A leading medical technology company in Kuala Lumpur is seeking a Senior Quality Engineer to ensure regulatory compliance across the Quality Management System. The ideal candidate will have at least 6 years of experience in the regulated Medical Device industry and a strong capability in managing Non-Conformance Reports. This role involves working closely with cross-functional teams to identify and implement improvements for compliant product production while providing guidance on standards such as ISO 13485 and FDA regulations.

Benefits

Career development opportunities

Collaborative work environment

Qualifications

• Minimum of 6 years in Quality or manufacturing in regulated Medical Devices.
• At least 4 years as a Senior Quality Engineer.
• Experience managing Non-Conformance Reports (NCRs) and Corrective Actions.

Responsibilities

• Ensure regulatory compliance across the Quality Management System.
• Support production and engineering teams with quality issues.
• Conduct and manage internal and external audits.

Skills

Regulatory compliance knowledge

Non-Conformance Report (NCR) management

Analytical skills

Quality Management System (QMS) experience

Interpersonal and stakeholder management

Education

Bachelor's degree in Electrical / Mechanical Engineering or equivalent

Tools

Microsoft Excel

Power BI

Quality Management tools

Job description

A leading medical technology company in Kuala Lumpur is seeking a Senior Quality Engineer to ensure regulatory compliance across the Quality Management System. The ideal candidate will have at least 6 years of experience in the regulated Medical Device industry and a strong capability in managing Non-Conformance Reports. This role involves working closely with cross-functional teams to identify and implement improvements for compliant product production while providing guidance on standards such as ISO 13485 and FDA regulations.