Quality Assurance Manager (Medical Lab / Office Hours)

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

Company Profile

Join one of Singapore’s leading academic health systems, recognised for its excellence in healthcare, research, and education. The organisation has been ranked among The Straits Times’ Best Employers and listed in the Top 10 of Singapore’s Leading Employer Awards, reflecting its strong commitment to employee growth and engagement.

With a people-first culture, they are dedicated to staff development and workplace well-being. You can look forward to a meaningful career with an organisation that values innovation, compassion, and excellence in advancing health for the community.

Work location: North

Working hours: Monday to Friday, 8.30am to 6pm

Responsibilities:

• Ensure compliance with regulatory and accreditation standards, including ISO 15189, CAP, CLIA and MOH requirements.
• Lead and coordinate internal, external and accreditation audits, including audit preparation, findings management and follow-up.
• Develop, implement and maintain the Quality Management System (QMS), including policies, SOPs, manuals and document control.
• Monitor compliance with established procedures and drive continuous quality improvement across laboratory operations.
• Manage quality incidents, complaints and non-conformances, including Root Cause Analysis (RCA) and Corrective and Preventive Actions (CAPA).
• Monitor key quality indicators such as turnaround time (TAT), error rates and specimen rejection rates, and lead improvement initiatives.
• Support proficiency testing / EQAS activities and monitor corrective actions arising from quality assessments.
• Identify and assess operational and strategic risks, developing appropriate mitigation and business continuity plans.
• Develop and monitor Key Risk Indicators (KRIs) and support Enterprise Risk Management (ERM) and Internal Governance (IG) activities.
• Conduct risk and governance audits and prepare risk assessments, management reports and stakeholder updates.
• Work closely with laboratory, clinical and corporate stakeholders to strengthen quality, risk management and regulatory compliance.
• Lead and mentor team members while driving quality and risk initiatives across functions.

Requirements:

• Degree in Medical Laboratory Science or a related discipline.
• Min. 2–5 years of experience in a core laboratory environment focusing on laboratory regulatory compliance, accreditation and Quality Management Systems (QMS) within a public or private healthcare institution.
• Good understanding of Risk Management and Quality Management Systems (QMS).
• American Society for Clinical Pathology (ASCP) and/or Enterprise Risk Management (ERM) certification is an advantage.
• Proficient in Microsoft 365, IT applications and AI tools.
• Minimum 2 years of leadership experience, with demonstrated ability to lead teams and cross-functional quality and risk initiatives.

Celine Chan I Reg. No: R21103433

EnviroDynamics Solutions Pte Ltd I EA License No.: 12C6285