Roles & Responsibilities

Support the Quality Manager to establish & maintain an effective and best-in-class quality management system & processes in compliance to 21CFR Part 820 QSR, ISO 13485 & ISO 9001 Quality Management System standards, and meeting customers as well as relevant statutory & medical device regulatory requirements.

The key roles and responsibilities are as below:

• Establish, implement, and maintain quality systems in accordance with ISO standards such as ISO 13485, ISO 9001, ISO 14001, and FDA 21 CFR Part 820.
• Develop and manage internal audits and audit schedules; lead a team of auditors to ensure compliance with FDA 21 CFR Part 820 and ISO 13485.
• Promote continuous improvement in all aspects of quality matters.
• Optimize site processes to ensure high performance.
• Oversee document control functions.
• Manage operational efficiency through proactive oversight of the CAPA process.
• Initiate programs to standardize training and increase efficiency.
• Manage external audits conducted by certification bodies, regulatory agencies, or customers.
• Prepare executive presentations for management review.
• Perform any other tasks as assigned.

What skills and experiences are we looking for?

• Diploma and/or Degree in any technical disciplines with at least 3 years of QA/QC working experience in a medical related industry.
• Familiar with the Quality Management Systems requirements such as ISO9001, ISO13485, and 21CFR Part 820 QSR preferred.
• Knowledge in IATF16949 will be an advantage.
• Excellent analytical, presentation, written and verbal communication abilities.

The Talent People 24C2589