Global Quality Systems Leader - Medical Devices

5G-Starlink Pte.; Singapore; On-site; SGD 120,000 - 190,000; Full time

Job summary

HOYA Surgical Optics is looking for a Quality System Manager to develop and sustain the QMS across its entities and elevate regulatory compliance. The role will lead continuous improvement, drive global QMS practices, and coordinate audits with HOYA Corporation and external bodies.

The candidate will manage CAPA, develop training on quality/compliance, and oversee QMS across international sites while traveling up to 25% to US, Europe, and Asia regions.

Qualifications

• Degree in Engineering or equivalent technical experience.
• Formal education on Quality Management preferred.

Responsibilities

• Lead the Quality System function to ensure QMS development and regulatory compliance.
• Establish, implement, and maintain QMS across HOYA Surgical Optics entities.
• Develop the Management Systems strategy and milestones; track progress against plan.
• Implement all procedures described in the QMS and ensure global procedures are updated for regulatory requirements.
• Drive standardization of practices across the company through collaboration with regional Quality Heads.
• Oversee QMS implementation and ensure compliance in local sites.
• Own the MasterControl platform and maintain related content.
• Develop and maintain a training platform on quality and compliance with HR.
• Support CAPA management and data gathering for Global Management Review.
• Lead quality improvement projects and continual improvements of QMS.

Skills

Quality Systems

Regulatory Compliance

Leadership

Project Management

Auditing

Education

Engineering degree

Quality Management training

Tools

MasterControl

Power BI

Microsoft Office

Job description

HOYA Surgical Optics is looking for a Quality System Manager to develop and sustain the QMS across its entities and elevate regulatory compliance. The role will lead continuous improvement, drive global QMS practices, and coordinate audits with HOYA Corporation and external bodies.

The candidate will manage CAPA, develop training on quality/compliance, and oversee QMS across international sites while traveling up to 25% to US, Europe, and Asia regions.