Quality Assurance Lead

22 hours ago

San Fernando, Central Luzon, Philippines beBeeQuality Full time ₱800,000 - ₱1,300,000

Quality Assurance Lead

Your primary responsibilities will be to oversee and support quality management processes and teams.

Maintain a robust quality management system in accordance with ISO 13485 and ISO 9001 standards, ensuring overall compliance with standard operating procedures.

You will be responsible for developing audit programs and plans, conducting internal audits, and coordinating external audits. Identify opportunities for process improvements and work with subject matter experts to implement changes.

CAPA management and regulatory compliance are essential aspects of this role. This includes maintaining up-to-date libraries of applicable standards and regulations across global markets.

Facilitate risk management in accordance with best practices, including ISO 14971, IEC 60812, and ISO 31000, and manage quality for the development of medical devices according to regulations such as CE MDR, FDA, and TGA, and standards including ISO 13485, IEC 60601, and IEC 62304.

Select and evaluate suppliers, monitor quality agreements, and manage actions arising from goods inspections, while promoting QMS regulatory requirements to all staff.

Key skills and experience required:

  • Relevant qualification
  • At least 5 years' experience in quality management or a similar role
  • In-depth knowledge of ISO 13485 and ISO 9001
  • Understanding of production/manufacturing processes

About our company

We are a leading product design team passionate about creating innovative, human-centric products. We offer a unique opportunity to work on a diverse range of products, showcase your expertise in design, and bring cutting-edge products to life.

We provide a full turn-key service for our customers and a unique opportunity for creative, passionate, professional designers and engineers to develop their skills with us.

Our team spans industrial and mechanical design, electronics, embedded systems, iOS, Android, Linux app, web servers, and more.

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