Laboratory Quality & Compliance Leader — QMS & Risk

EnviroDynamics Solutions Pte Ltd; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

EnviroDynamics Solutions Pte Ltd is seeking a Quality & Risk Lead for our Singapore North operations. You will drive QMS development, regulatory compliance, and audits across the lab network, ensuring data integrity and patient safety.

You will lead cross-functional teams, manage CAPA, and monitor KRIs and TAT, while mentoring staff and coordinating with stakeholders to advance quality and governance initiatives.

Qualifications

• Degree in Medical Laboratory Science or related discipline.
• 2–5 years in a core laboratory focusing on regulatory compliance, accreditation and QMS.
• Good understanding of Risk Management and QMS.
• ASCP and/or ERM certification is an advantage.
• Proficient in Microsoft 365, IT applications and AI tools.

Responsibilities

• Ensure compliance with regulatory and accreditation standards (ISO 15189, CAP, CLIA and MOH).
• Lead and coordinate internal, external and accreditation audits.
• Develop, implement and maintain the 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 like TAT, error rates and specimen rejection.
• Support proficiency testing/EQAS activities and corrective actions.
• Identify and assess operational and strategic risks with mitigation plans.
• Develop KRIs and support ERM and IG activities.
• Conduct risk and governance audits and prepare risk assessments and reports.
• Collaborate with lab, clinical and corporate stakeholders to strengthen quality and risk.
• Lead and mentor team members across quality and risk initiatives.

Skills

Quality management

Risk management

Audits coordination

Root Cause Analysis

Stakeholder coordination

Regulatory compliance

Quality improvement

Leadership

Problem solving

Education

Degree in Medical Laboratory Science

Min. 2–5 years of experience in core laboratory with regulatory compliance, accreditation and QMS

Minimum 2 years of leadership experience

ASCP and/or ERM certification advantageous

Tools

Microsoft 365

IT applications

AI tools

Job description

EnviroDynamics Solutions Pte Ltd is seeking a Quality & Risk Lead for our Singapore North operations. You will drive QMS development, regulatory compliance, and audits across the lab network, ensuring data integrity and patient safety.

You will lead cross-functional teams, manage CAPA, and monitor KRIs and TAT, while mentoring staff and coordinating with stakeholders to advance quality and governance initiatives.