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).