OBJECTIVE

To support the implementation, maintenance, and continuous improvement of the Quality Management System (QMS) while ensuring compliance with applicable regulatory, legal, and customer requirements. The role contributes to quality assurance, regulatory affairs, supplier management, compliance activities, and audit readiness in accordance with ISO 9001, ISO 13485, and other applicable regulations.
RESPONSIBILITIES
- - Quality Management System (QMS)

Draft, review, and maintain Quality System documentation, including Standard Operating Procedures (SOPs), Work Instructions, Forms, and Quality Records.

Support the implementation and continuous improvement of the QMS in compliance with ISO 9001, ISO 13485, and any other applicable current or future regulatory, quality, and industry requirements.

Ensure document control activities are performed according to established procedures.

Support Quality System training activities and maintain training records as required.
- - CAPA and Non-Conformity Management

Manage and coordinate non-conformities, deviations, complaints,



and corrective and preventive actions (CAPA).

Participate in root cause investigations and effectiveness verification activities.

Monitor CAPA progress and ensure timely closure of actions.

Support continuous improvement initiatives.
- - Audit Management

Prepare, coordinate, and support internal audits, certification audits, supplier audits, and customer audits.

Develop audit plans, schedules, checklists, and audit reports.

Coordinate responses to audit findings and ensure implementation of corrective actions.

Monitor follow-up actions arising from audits.
- - Regulatory Affairs

Prepare, review, and maintain regulatory documentation required by customers, certification bodies, notified bodies, competent authorities, or other stakeholders.

Support product registrations, certifications, declarations, and regulatory submissions when applicable.

Monitor regulatory changes and communicate r

📌 Corporate QA/RA Specialist (Barcelona)
🏢 Sensofar
📍 Barcelona