Senior Quality Systems Specialist (18-month contract)

Aquí tienes el perfil de Senior Quality Management System Specialist con un formato optimizado y profesional: What You Will Do This role is accountable for building, maintaining, and continuously improving a Quality Management System (QMS) 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 QMS Compliance: Maintain alignment with internal and external regulatory requirements, including site, corporate, FDA, ISO, EU MDR, and country-specific regulations. Process Development: Implement and control updates to regional and local quality management system processes in line with corporate and divisional requirements. Audit Management: Support and coordinate internal and external audits, including preparation, execution, and follow-up activities. Management Review: Lead Management Review forums, preparing meeting minutes and tracking follow-up action items to closure. Continuous Improvement: Participate in the development and maintenance of quality policies and procedures. Documentation Approval: Review and approve quality compliance documentation, including non-conformances (NCs), CAPAs (Corrective and Preventive Actions), and change controls. Document Control: Manage routing, release, distribution, archiving, and retrieval of documents to ensure availability and accuracy. Regulatory Correspondence: Coordinate information requests from health authorities and customers, ensuring proper notification to corporate regulatory and quality teams. What You Will Need Required Education: Bachelor’s degree in Engineering, Science, or Business Administration. Experience: Minimum 4 years of regulatory or quality systems experience in the medical device industry or an FDA-regulated environment. Background: Prior experience working in a legal, technical, or regulatory environment. Languages: Proficiency in English and Spanish (written and verbal, business level). Tools: Advanced knowledge of MS Office. Preferred Certifications: Quality or regulatory certification (e.g., Certified Quality Auditor, Certified Quality Engineer, Six Sigma). Lead Auditor: Certified Lead Auditor for ISO 13485:2016. Technical Systems: Experience working with electronic quality or document management systems (eQMS).