Director, Quality System and Regulatory Compliance

HOYA Surgical Optics

Director overseeing quality systems and regulatory compliance initiatives at HOYA Vision Care. Leading global QMS implementation and internal audit improvements.

Posted 5/13/2026full-timeSingapore • 🇸🇬 SingaporeLeadWebsite

About the role

Key responsibilities & impact

Develop, implement, and maintain the QMS across HVC entities
Oversee and ensure compliance of all quality systems elements to regulatory requirements and quality standards
Define QMS architecture for implementation across HVC sites
Drive implementation of One Global Management system in HVC, develop Global procedures for key processes
Support the CQO in the implementation of strategies to monitor and improve the level of regulatory compliance in HVC
Prepare HVC sites for authorities audits and support these audits as required
Drive the standardization of practices across HVC through the establishment and maintenance of a global quality manual
Own e-QMS platform
Lead the project of the new e-QMS system implementation and ensure successful implementation and transition in all HVC sites
Manage Global Internal audit program, coordination with Hoya Corporation audits

Requirements

What you’ll need

Degree in Engineering, Quality, or equivalent technical experience
Formal education in Quality Management preferred
Auditor certification by IRCA as a plus
10-12 years of experience in Regulatory compliance, Quality Assurance or Quality Systems in regulated industry (pharma or medical device)
Must have managed external audits of Notified Bodies, & preferably FDA
Must have monitored product quality in production or in the field
Strong knowledge of QMS requirements and quality and regulatory compliance.
Strong knowledge of ISO13485 and other regulatory requirements such as PMDA, US FDA and other critical regulators
ISO 13485 certified lead auditor with experience in establishing and leading Internal audit program.
Min 5 years’ experience of managing team

Benefits

Comp & perks

Willingness to travel up to 35%, mainly to Thailand, Japan, Europe, and USA.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

QMS developmentregulatory compliancequality assuranceinternal audit managemente-QMS implementationISO 13485quality systemsaudit preparationglobal procedures developmentquality manual standardization

Soft Skills

leadershipproject managementstrategic planningcommunicationteam managementorganizational skillsproblem-solvingcollaborationattention to detailadaptability

Certifications

IRCA auditor certificationISO 13485 lead auditor certification