Quality Management System Executive

3 weeks ago

Singapur, Singapore CorDx Full time

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.
Qualifications
  • 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.
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