What You Will Do

This role is accountable for building maintaining and continuously improving a Quality Management System that meets global medical device regulatory requirements. As a Senior Specialist you will guide QMS development and execution across the organization ensuring regulatory readiness audit compliance and alignment with corporate quality standards.

• Ensure Quality Management System (QMS) compliance with applicable internal and external regulatory requirements including site corporate FDA ISO EU MDR and countryspecific regulations.

• Develop implement and control updates to regional and local quality management system processes aligned with corporate and divisional QMS requirements.

• Support the management and coordination of internal and external audits including preparation execution and followup activities.

• Coordinate and lead Management Review forums in accordance with applicable procedures including preparation of meeting minutes and followup action items to closure.

• Participate in the development maintenance and continuous improvement of quality policies and procedures.

• Review and approve quality compliance documentation including nonconformances corrective and preventive actions and change controls as required.

• Manage document control activities including routing release distribution archiving and retrieval to ensure current documentation is available as required.

• Coordinate regulatory correspondence and additional information requests from health authorities and customers including notifications to corporate regulatory and quality teams.

What You Will Need

Required

• Bachelors degree in engineering science or business administration.

• Minimum 4 years of regulatory or quality systems experience within the medical device industry or another FDAregulated manufacturing environment.

• Prior experience working in a legal technical or regulatory environment.

• Proficiency in English and Spanish (written and verbal business level).

• MS Office knowledge

Preferred

• Quality or regulatory certification (e.g. Certified Quality Auditor Certified Quality Engineer Six Sigma).

• Certified Lead Auditor for ISO 13485:2016.

• Experience working with electronic quality or document management systems.