Quality Assurance Executive

About the Role

The Quality Assurance Executive will support Cordlife Singapore in implementing and continuously enhancing the Quality Management System (QMS), ensuring it aligns with regulatory, accreditation, and internal standards. This position involves spearheading quality assurance activities, supporting both internal and external audits, managing quality records and documentation, investigating issues, facilitating corrective actions and risk management, and fostering ongoing quality improvements throughout the company.

Key Responsibilities

• Maintain and improve the QMS to comply with regulatory mandates and accreditation benchmarks such as MOH, AABB, ISO, FACT, GDP, and MDS SS 620.
• Oversee quality metrics, handle deviations, CAPA processes, and perform risk evaluations while driving continuous enhancement projects.
• Execute internal audits, assist with external audits, and guarantee adherence to quality and regulatory policies.
• Administer document and change control, maintain comprehensive quality records, and generate reports to uphold system integrity and traceability.
• Assist in supplier/vendor qualification, contribute to regional quality programs, and engage in cross-departmental quality improvement initiatives.
• Collaborate with the QA Manager to recommend and enact corrective and preventive solutions, strengthening compliance and ensuring audit success.

Qualifications

• Bachelor’s Degree in Quality Management, Biological Sciences, Medical Sciences, or a related field.
• Between 1 and 3 years of experience in Quality Assurance, ideally within life sciences, biotechnology, healthcare, or other regulated sectors.
• Familiarity with Quality Management Systems, quality assurance principles, and regulatory compliance requirements.
• Experience or understanding of accreditation standards such as AABB, FACT, GDP, or MDS SS 620 is advantageous.
• Willingness to undertake additional duties as assigned.

Required Skills & Competencies

• Exceptional oral and written communication capabilities.
• Strong analytical, critical thinking, and problem-solving skills.
• Meticulous attention to detail and accuracy.
• Effective organizational and project management abilities.
• Capability to juggle multiple priorities within a regulated environment.
• Excellent interpersonal skills with the aptitude to collaborate across functional teams.
• Proactive mindset focused on quality and committed to continuous improvement.