Healthcare Lab Quality & Compliance Lead

EnviroDynamics Solutions Pte Ltd; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

EnviroDynamics Solutions Pte Ltd, a leading health systems partner in Singapore, seeks a Quality & Compliance Lead to oversee regulatory standards, develop and maintain the QMS, and drive continuous improvement across laboratory operations.

The role requires 2–5 years in a core lab with regulatory focus, leadership experience, and familiarity with ISO 15189, CAP, CLIA, MOH requirements. Strong communication and stakeholder collaboration are essential.

Qualifications

• Bachelor's degree in Medical Laboratory Science or related field.
• 2–5 years of experience in a core laboratory focusing on regulatory compliance and QMS.
• Strong understanding of Risk Management and QMS.
• ASCP and/or ERM certification is an advantage.
• Proficient in Microsoft 365, IT applications and AI tools.
• Minimum 2 years of leadership experience with cross-functional quality initiatives.

Responsibilities

• Ensure compliance with regulatory and accreditation standards (ISO 15189, CAP, CLIA, MOH).
• Lead internal, external and accreditation audits including preparation and follow-up.
• Develop and maintain the Quality Management System (QMS) with policies and SOPs.
• Monitor procedures and drive continuous quality improvement across lab operations.
• Manage quality incidents, complaints and non-conformances with RCA and CAPA.
• Monitor key quality indicators such as TAT, error rates, and specimen rejection rates.
• Support proficiency testing/EQAS activities and corrective actions.
• Identify operational and strategic risks; develop mitigation and business continuity plans.
• Develop and monitor KRIs; support Enterprise Risk Management and Internal Governance.
• Conduct risk and governance audits and prepare risk assessments and reports.
• Collaborate with stakeholders to strengthen quality, risk management and regulatory compliance.
• Lead and mentor team members to advance quality and risk initiatives.

Skills

Leadership

Regulatory compliance

Quality management

Audits

Risk management

Stakeholder management

Education

Bachelor's degree in Medical Laboratory Science

Tools

Microsoft 365

AI tools

IT applications

Job description

EnviroDynamics Solutions Pte Ltd, a leading health systems partner in Singapore, seeks a Quality & Compliance Lead to oversee regulatory standards, develop and maintain the QMS, and drive continuous improvement across laboratory operations.

The role requires 2–5 years in a core lab with regulatory focus, leadership experience, and familiarity with ISO 15189, CAP, CLIA, MOH requirements. Strong communication and stakeholder collaboration are essential.