QA Leader: ISO 15189 Readiness & Patient Safety

Personal Collection Direct Selling Inc.; Manila; On-site; PHP 1,800,000 - 3,600,000; Full time

Job summary

The Quality Assurance Head at Personal Collection Direct Selling Inc. will establish and lead the enterprise quality management system across laboratory and support operations, ensuring compliance with laws, DOH, and ISO requirements.

You will drive audits, CAPA, documentation controls, and risk-based quality initiatives, reporting on KPIs and leading the QA team to protect patient safety and result reliability.

Qualifications

• Bachelor’s degree and relevant health science licensure preferred.
• 8+ years in healthcare quality with leadership.
• Experience with ISO 15189, ISO 9001, DOH requirements, audits, CAPA.

Responsibilities

• Lead and improve the QMS across sites and operations.
• Drive ISO 15189/9001 readiness and regulatory compliance.
• Develop and execute risk-based quality audits.
• Manage quality incidents, CAPA, and root-cause analysis.
• Oversee documentation, records, and change control.
• Establish KPIs and dashboards; report trends and risks.
• Facilitate quality reviews with senior leadership.
• Lead patient safety escalations and risk response.
• Collaborate with Clinical Ops, Medical, HR, Legal, IT, Finance, and Ops.
• Develop QA team and training.

Skills

Quality management

Leadership

Data analysis

Risk assessment

Root-cause analysis

Quality reporting

Education

Bachelor’s degree in Medical Technology/Medical Laboratory Science or Healthcare Quality

Tools

Document control

Job description

The Quality Assurance Head at Personal Collection Direct Selling Inc. will establish and lead the enterprise quality management system across laboratory and support operations, ensuring compliance with laws, DOH, and ISO requirements.

You will drive audits, CAPA, documentation controls, and risk-based quality initiatives, reporting on KPIs and leading the QA team to protect patient safety and result reliability.