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Quality Control and Improvement Specialist

2 weeks ago

Singapore Quasarmedical Full time

We are looking for a Quality Control and Improvement Specialist to join our team at Quasarmedical. In this role, you will be responsible for ensuring the quality and regulatory compliance of medical devices throughout the manufacturing process.

Your key responsibilities will include:

  • Developing, implementing, and maintaining quality assurance plans, procedures, and control measures.
  • Monitoring and analyzing production processes to detect and resolve quality issues.
  • Ensuring compliance with relevant regulatory requirements, including FDA, ISO 13485, and other applicable standards.
  • Supporting internal and external audits and regulatory inspections.
  • Investigating and resolving product-related issues, deviations, and non-conformities, with the authority to recommend corrective and preventive actions.

You will also participate in new product introductions, support validation processes, and lead QA initiatives. To succeed in this role, you will need:

  • A degree in Engineering or science, with 2–5 years of progressive quality responsibility, preferably in medical device/pharmaceutical manufacturing.
  • Knowledge of regulatory requirements and quality standards, including FDA regulations and ISO 13485 standards.
  • A good command of the English language.
  • Strong analytical and problem-solving skills, with the ability to troubleshoot complex issues.
  • Effective collaboration with cross-functional teams and clear presentation of information.

In return, you can expect a challenging and rewarding role that contributes to the development of high-quality medical devices.