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Quality Management System Executive
CorDx · Singapore · Not Specified
Quick Summary
- Develop and maintain Quality Management System per ISO 13485 and GDPMDS standards.
- Manage documentation and ensure compliance with regulatory requirements.
- Prepare for audits and conduct employee training on quality policies.
Full Description
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.