Global QMS Lead Auditor (Medical Devices)

Sonova Group; Barcelona; Híbrido; EUR 60.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flexible hybrid model

Training opportunities

Development plans

Descripción de la vacante

Sonova Group is seeking a QMS Lead Auditor in Barcelona to strengthen our global Quality Management System. You will lead internal audits across international medical device entities, ensuring compliance with ISO standards and internal procedures while driving sustainable improvements.

The role offers significant exposure to global operations, collaboration across diverse teams, and a flexible hybrid working model with travel approx. 40%.

Formación

• A bachelor's degree in quality management, engineering, life sciences, medical technology, regulatory affairs or related field.
• At least five years of experience in Quality Management Systems or regulatory affairs, ideally in medical devices, with demonstrated auditing competence.
• Documented training in standards and regulations (ISO 13485, ISO 9001, MDSAP, EU MDR) and Lead Auditor certification.
• Deep knowledge of core quality processes (audits, CAPA, non-conformances, change control) with risk-based, evidence-led approach.
• High integrity, independence and resilience with strong analytical skills and attention to detail.
• Clear, respectful communication, active listening, interviewing and facilitation in multicultural environments.
• Fluent business English; Portuguese or Spanish skills are a plus.
• Willingness to travel ~40% globally

Responsabilidades

• Lead internal QMS audits across international medical device entities from planning to follow-up.
• Prepare risk-based audit plans covering scope, objectives, standards, sampling, checklists and prior findings.
• Review pre-audit information and assess the effectiveness and regulatory compliance of quality processes.
• Conduct stakeholder interviews, collect evidence and document audit results with risk-based findings.
• Communicate outcomes to site management and stakeholders; review proposed corrections and corrective actions.
• Lead cross-functional audit teams by coordinating co-auditors and topics; ensure consistent evidence collection.
• Support auditor qualification, checklist development, audit learning and ongoing program effectiveness.

Conocimientos

Auditing

Quality management

Regulatory affairs

ISO 13485

MDSAP

EU MDR

Risk management

Communication

Travel readiness

Lead Auditor

Educación

Bachelor degree

Descripción del empleo

Sonova Group is seeking a QMS Lead Auditor in Barcelona to strengthen our global Quality Management System. You will lead internal audits across international medical device entities, ensuring compliance with ISO standards and internal procedures while driving sustainable improvements.

The role offers significant exposure to global operations, collaboration across diverse teams, and a flexible hybrid working model with travel approx. 40%.