Quality Engineer - Medical Devices

About the Company:

This employer is a globally established company that provides specialized materials essential for protecting sterile medical products. Trusted by leading medical device and pharmaceutical manufacturers, they play a vital role in supporting safe product delivery across hospitals, surgical centres and labs. They are now focused on expanding their regional presence in Malaysia.

About the Job:

In this position, you will ensure quality compliance in medical device manufacturing. You'll maintain ISO 13485 standards, monitor production processes, conduct audits, and implement improvements while collaborating with other departments to uphold medical device packaging quality standards.

Job Responsibilities:

• Ensure compliance with ISO 13485 standards by monitoring quality systems and implementing continuous improvement initiatives in medical device packaging production.
• Conduct quality risk assessments and validate production processes to maintain consistency and adherence to healthcare packaging standards.
• Perform internal audits of quality management systems and support external certification audits to maintain regulatory compliance.
• Analyse quality data and non-conformance reports to identify trends, implement corrective actions, and prevent recurring issues in medical packaging production.
• Collaborate with cross-functional teams to develop and maintain quality documentation, including standard operating procedures, work instructions, and validation protocols specific to healthcare packaging.

Job Requirements:

• Bachelor’s degree in Engineering
• Basic knowledge of ISO 13485
• Understanding of production processes and Quality Management Systems
• Experience in internal and/or external audits will be an added advantage
• Experience working in medical device industry

What’s on offer:

• Exciting career progression opportunities in a rapidly expanding company
• Competitive remuneration and benefits (RM 5000 – RM 6000)
• The chance to be part of a growth industry that makes a difference in people’s lives