Quality Manager

About the role

The Quality Manager is a full‑time, on‑site position based in Bataan. The role oversees and continuously improves all quality‑related activities within the manufacturing facility. It leads the development, implementation, and maintenance of a robust Quality Management System to satisfy internal, customer, and regulatory requirements.

Key responsibilities

• Develop, implement and maintain the Quality Management System (QMS) in line with ISO 9001 and other applicable standards.
• Monitor product quality performance, analyse data trends and drive corrective and preventive actions.
• Lead root‑cause investigations using methodologies such as 8D, QRQC and ensure effective action‑plan implementation.
• Coordinate internal and external audits, manage non‑conformities and oversee calibration and validation of equipment.
• Support production, engineering and supply‑chain teams in problem‑solving and process‑capability improvement.
• Ensure compliance with FDA (CMDN) requirements and other medical regulatory mandates.
• Train and mentor quality staff and promote a culture of continuous improvement.

Required profile

• B.S. degree in Engineering or a scientific discipline.
• Minimum of 5 years of experience in quality assurance within a manufacturing environment.
• ISO training certification and experience with ISO standards, calibration standards, and Management of Change.
• DPO certification and knowledge of medical regulatory requirements.
• Excellent written communication skills and fluency in English.

Required skills

• Total Quality Management.
• Problem‑solving techniques (8D, QRQC).
• Statistical Process Control (SPC).
• Quality tools such as FTA and Ishikawa Diagram.
• Risk assessment and Failure Mode and Effects Analysis (FMEA).
• ISO 9001 and related quality standards.
• Calibration standards and equipment validation.
• Management of Change.
• Customer complaint handling and CAPA processes.
• DPO certification.
• Medical regulatory compliance (FDA, CMDN).