Clinical Quality & Risk Lead — Lab Compliance

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

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.

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