Quality and Compliance Officer

5 days ago

Makati Central Post Office P, Philippines Medi Linx Laboratory, Inc Full time

The Quality and Compliance Officer ensures that all Medi Linx Laboratory Inc. (MLLI) clinical laboratories comply with applicable local and international standards, regulatory requirements, and accreditation guidelines (e.g., DOH, ARSP, JCI, CAP, ACI, ISO).

The role supports the consistent implementation of the Quality Management System (QMS), coordinates internal audits, and drives continuous quality improvement initiatives across all facilities.

RESPONSIBILITIES:

Regulatory and Accreditation Compliance

  • Ensure compliance with Department of Health (DOH) licensing requirements, regulatory circulars, and accreditation standards (e.g., ARSP, CAP, ACI).
  • Conduct internal audits, risk assessments, and compliance reviews to ensure readiness for regulatory inspections and accreditation audits.
  • Assist in drafting responses and action plans for regulatory inspections, audits, and external assessments.
  • Coordinate with regulatory and accrediting bodies, serving as liaison when needed.

Quality Management and Improvement

  • Monitor and ensure implementation of the Quality Management System (QMS) across all clinical laboratories.
  • Monitor laboratory quality indicators, key performance metrics, and Balanced Scorecards.
  • Lead investigations and root cause analyses of incidents, non-conformances, and equipment failures.
  • Recommend and implement best practices to enhance operational efficiency, accuracy, and patient safety.
  • Collaborate with the Quality, Kaizen, and Safety Officers to identify laboratory-specific requirements and develop improvement recommendations.

Documentation and Process Control

  • Coordinate document control, policy updates, and the implementation of corrective and preventive actions (CAPA).
  • Ensure the document registry is current, accurate, and complete.
  • Review and approve new test items and equipment in coordination with Quality Officers.

Performance Monitoring and Reporting

  • Monitor proficiency testing, method validation, and equipment verification programs.
  • Analyze turnaround times (TAT), incident occurrence rates (IOR), and other key performance indicators (KPIs).
  • Prepare compliance and performance dashboards for management review.
  • Review NPS feedback with BD, Marketing, and Clinical Laboratory Operations, providing recommendations to address quality-related concerns.

Certification and Standards Management

  • Support the organization's efforts to acquire and maintain international certifications and standards related to service and quality (e.g., CAP, ISO, JCI).

QUALIFICATIONS:

  • Bachelor's degree in Medical Technology, Laboratory Science, or related field
  • At least 3–5 years of experience in laboratory quality assurance or compliance roles.
  • Strong knowledge of QMS, CAP/ISO standards, and DOH regulatory requirements.
  • Excellent analytical, problem-solving, and documentation skills.
  • Effective communication and interpersonal abilities, with experience conducting training or audits.

Job Types: Full-time, Permanent

Benefits:

  • Additional leave
  • Health insurance

Work Location: In person

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