Quality Management System Executive at CordX

Key Responsibilities:

• Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485, GDPMDS, and other applicable regulations.
• Ensure compliance with local and international regulatory requirements, including HSA (Health Sciences Authority) regulations for IVD devices in Singapore.
• Manage documentation processes, including SOPs, work instructions, and records, to ensure accuracy and compliance.
• Prepare for and participate in internal and external audits, including regulatory inspections and customer audits.
• Conduct training sessions for employees on quality policies, regulatory updates, and best practices in quality management.
• Assist in risk assessment and mitigation activities related to product quality and regulatory compliance.
• Investigate non-conformances, implement corrective and preventive actions (CAPA), and monitor their effectiveness.
• Support supplier audits and evaluations to ensure adherence to quality standards.
• Identify opportunities for process improvements and work with teams to enhance efficiency and effectiveness.

Requirements

• Bachelor’s degree in Life Sciences, Biotechnology, Biomedical Engineering, or a related field.
• Minimum of 2 years of experience in quality management, regulatory affairs, or related roles within the medical device or IVD industry.
• Familiarity with ISO 13485, GDPMDS, EU IVDR, FDA QSR, and Singapore’s HSA regulations.
• Skills:
• Strong understanding of quality management principles and regulatory requirements.
• Excellent organizational and documentation skills.
• Strong analytical and problem-solving skills.
• Effective communication and teamwork abilities.
• Ability to work independently and manage multiple tasks efficiently.
• Certifications (Preferred): ISO 13485 Lead Auditor or other relevant quality certifications.