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 relevant updates to the organization.
Provide regulatory guidance to internal departments.
Prepare, review, and maintain Quality Assurance Agreements (QAAs), supplier quality agreements, and customer quality agreements.
Support the review of legal agreements and contracts related to quality, regulatory, and compliance requirements.
Collaborate with external legal advisors when necessary.

- - Cross-functional QA & RA Support

Provide quality, regulatory, and compliance support to other functional areas across the organization, including activities related to supplier quality, corporate compliance, cybersecurity, and any other current or future requirements falling within the scope of the QA & RA function.
Contribute to cross-functional projects and initiatives led by or involving the QA & RA area, providing support according to business needs, regulatory developments, and departmental priorities.

KEY QUALIFICATIONS AND EXPERIENCE

- Bachelor’s degree in a relevant scientific or engineering field (e.g., biology, chemistry, biomedical engineering).
- Additional training in Quality Management Systems or Regulatory Affairs is considered an asset.
- 2+ years of experience in regulated industries (medical devices preferred).

OTHER SKILLS

- Good knowledge of ISO 9001 requirements; knowledge of ISO 13485 is considered an asset.
- Understanding of Quality Management System processes, including CAPA, non-conformity management, document control, and supplier qualification.
- Familiarity with medical device regulations and regulatory documentation requirements.
- Strong organizational, analytical, and problem-solving skills.
- Excellent communication and technical writing skills.
- Good command of English (written and spoken).

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