## Senior Quality Systems Specialist (18-month contract)Applylocations: Tijuana, Mexicotime type: Full timeposted on: Posted 9 Days Agotime left to apply: End Date: May 8, 2026 (1 day left to apply)job requisition id: R Work Flexibility: Onsite# **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 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.# **What You Will Need****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.Travel Percentage: 10%#J-18808-Ljbffr