Work Flexibility: Onsite

What You Will Do

This role is accountable for building, maintaining, and continuously improving a Quality Management System that meets general 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%

📌 Senior Quality Systems Specialist (18-month contract) (Tijuana)
🏢 Stryker
📍 Tijuana