Job details
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.
