Engineer, Quality Management System

1 week ago


Singapore THE TALENT PEOPLE PTE. LTD. Full time
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

Tell employers what skills you have

Troubleshooting
CAPA
FDA
Verbal Communication
Construction
Quality Management
Hardware
Quality Management Systems
ISO
Scripting
SQL
Compliance
ISO 9001
Networking
Python
Windows
Java
Manufacturing
Electronics
Software Development

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