Clinical Quality Manager (5 days / Office Hours)

EnviroDynamics Solutions Pte Ltd

Singapore

On-site

SGD 60,000 - 100,000

Full time

11 days ago
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Job summary

EnviroDynamics Solutions Pte Ltd, based in Singapore, is seeking a Quality & Risk Management Specialist to strengthen regulatory compliance and accreditation efforts across the laboratory operations.

You will lead audits, develop and maintain the QMS, monitor KPIs, and drive continuous improvement with cross-functional teams. Ideal candidates have 2–5 years in lab compliance, ASCP/ERM certification a plus, and strong leadership.

Qualifications

  • Degree in Medical Laboratory Science or related field.
  • Min. 2–5 years experience in core laboratory regulatory compliance and QMS.
  • Good understanding of risk management and QMS.
  • ASCP and/or ERM certification is an advantage.
  • Proficient in Microsoft 365 and IT tools.

Responsibilities

  • Ensure compliance with regulatory and accreditation standards such as ISO 15189, CAP, CLIA and MOH.
  • Lead and coordinate internal, external and accreditation audits.
  • Develop, implement and maintain the QMS (policies, SOPs, document control).
  • Monitor procedures and drive continuous quality improvement.
  • Manage quality incidents and non-conformances including RCA and CAPA.
  • Monitor quality indicators and lead improvement initiatives.
  • Support proficiency testing activities and corrective actions.
  • Identify operational and strategic risks with mitigation plans.

Skills

Quality management
Regulatory compliance
Audits
Risk management
QMS
Leadership

Education

Degree in Medical Laboratory Science

Tools

Microsoft 365
IT applications
AI tools

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

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