Quality Systems Leader: ISO & CAPA Excellence

EssilorLuxottica; Biñan; On-site; PHP 720,000 - 1,200,000; Full time

Job summary

EssilorLuxottica seeks a Quality Management Systems Supervisor to lead the implementation, maintenance, and continuous improvement of the QMS across our site. You will oversee internal audits, document control, CAPA, and quality programs to ensure ISO standards, regulatory requirements, and customer expectations are met.

The role requires collaboration with cross-functional teams to drive quality metrics, governance, and compliance, while fostering a culture of quality and continuous improvement

Qualifications

• Bachelor's degree in Engineering, Quality Management, Industrial Engineering, Manufacturing Engineering, or sciences related discipline.
• Proficiency in maintaining ISO13485-certified Quality Management Systems
• Experience in manufacturing environments, preferably Medical Devices and Optical Manufacturing
• Proficiency in Risk Management, Technical Risk Analysis, Quality and Problem solving tools.

Responsibilities

• Ensure the organizations continued compliance and certification to applicable international quality standards (e.g., ISO 13485, ISO 9001) and regulatory requirements, including FDA and customer-specific requirements, through effective deployment, monitoring, and continuous improvement of the Quality Management System (QMS).
• Lead the planning, execution, and continuous enhancement of the Internal Audit Program by coordinating with cross-functional teams, ensuring audit schedules and frequencies are met, identifying compliance gaps, and driving timely and effective closure of audit findings.
• Manage the Corrective and Preventive Action (CAPA) System, ensuring timely initiation, investigation, root cause analysis, implementation, effectiveness verification, and closure of CAPAs arising from internal audits, customer complaints, regulatory observations, and quality-related incidents.
• Develop, implement, and sustain quality awareness, competency development, and training programs that enhance employee understanding of QMS requirements and foster a culture of quality, compliance, ownership, and continuous improvement.
• Serve as Site Administrator and Subject Matter Expert for key Quality Systems, ensuring effective implementation, governance, compliance, and continuous improvement of the following programs: Global Management of Change (MOC), Risk Management, Technical Risk Analysis.
• Support customer, certification, corporate, and regulatory audits and inspections by ensuring audit readiness, maintaining compliance documentation, and coordinating the timely resolution of audit observations and findings.
• Collaborate with operational and support functions to strengthen quality processes, enhance process controls, and ensure alignment of quality objectives with organizational goals and customer expectations.

Skills

Quality management

Risk management

Technical risk analysis

Problem solving tools

Education

Bachelor's degree in Engineering, Quality Management, Industrial Engineering, Manufacturing Engineering, or sciences related discipline

Job description

EssilorLuxottica seeks a Quality Management Systems Supervisor to lead the implementation, maintenance, and continuous improvement of the QMS across our site. You will oversee internal audits, document control, CAPA, and quality programs to ensure ISO standards, regulatory requirements, and customer expectations are met.

The role requires collaboration with cross-functional teams to drive quality metrics, governance, and compliance, while fostering a culture of quality and continuous improvement