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 country‑specific 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 follow‑up activities.

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

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

• Review and approve quality compliance documentation, including non‑conformances, 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.

Required

• Bachelor’s degree in engineering, science, or business administration.

• Minimum 4 years of regulatory or quality systems experience within the medical device industry or another FDA‑regulated 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.