About the company
Our Client is a well-established medical device manufacturing industry precision medical consumables and surgical devices for healthcare facilities worldwide. The organization is hiring for Quality Manager, to lead quality function, establish robust quality systems, as well as drive quality excellence and improvement initiatives.
Responsibilities
Lead and manage the Quality Department, ensuring the effective implementation and maintenance of the Quality Management System in compliance with ISO 13485, FDA QSR 820, GMP, and relevant Malaysian regulatory requirements.
Oversee product quality activities, including non-conformance management, product release approvals, customer complaint handling, and CAPA implementation and follow-up.
Develop, review, and maintain quality procedures, work instructions, inspection standards, and quality documentation while supporting supplier audits, raw material evaluations, and new product introductions.
Plan and manage validation and verification activities for critical systems and projects, including sterilization processes, cleanrooms, water systems, packaging, ozone disinfection, and compressed air systems.
Coordinate regulatory inspections, customer audits, and quality assessments while ensuring corrective and preventive actions are effectively implemented.
Lead internal audits, management reviews, self-inspections, adverse event reporting, and medical device recall activities to maintain compliance and operational effectiveness.
Drive quality objectives, monitor key performance indicators, conduct regular quality review meetings, and lead continuous improvement initiatives across the organization.
Requirements
Possess Bachelor’s Degree in Medical Engineering, Industrial Engineering, Applied Sciences or equivalent.
Preferably with at least 7 years of quality management experience within a medical devices / medical components manufacturing environment.
Knowledge of Quality Management principles, ISO 13485 as well as Medical Devices compliances.
Capability in establishing and implementing quality systems for new plant operations.
Strong leadership, communication and problem-solving skills.
Interested candidates are welcomed to apply online.
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