QMS Lead Auditor

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

At Sonova, we envision a world where everyone can enjoy the delight of hearing. This vision inspires us and fuels our commitment to developing innovative solutions that improve hearing health and human connection - from personal audio devices and wireless communication systems to hearing aids and cochlear implants. We're dedicated to providing outstanding customer experiences through our global audiological care services, ensuring that everyone has the opportunity to engage fully with the world around them.

Here you’ll find a diverse range of opportunities that span both consumer and medical solutions and the freedom to shape your career while making an impact on the lives of others. Join us in our mission to create a more connected world, where every voice is heard and every story matters.

Barcelona, Spain

As QMS Lead Auditor, you will play an important role in strengthening the effectiveness and continual improvement of Sonova's global Quality Management System. You will lead internal audits across our international medical device entities, assessing compliance with applicable standards, regulations and internal procedures while helping stakeholders turn audit insights into sustainable improvements.
In return for your expertise, independence and sound judgement, you will gain broad exposure to global operations, collaborate with diverse teams and contribute to a quality culture that supports safe, compliant and innovative hearing care solutions. This is an international role involving approximately 40% travel and the opportunity to influence audit practices across multiple Sonova entities.

More about the role

• Lead assigned internal QMS audits, from initial planning and coordination through audit execution, reporting and follow-up.
• Prepare risk-based audit plans covering scope, objectives, applicable standards and regulations, sampling methods, relevant checklist sections and previous findings.
• Review pre-audit information and assess the effectiveness, adequacy and regulatory compliance of quality processes across international medical device entities.
• Conduct stakeholder interviews, collect objective evidence and document audit results clearly, including the risk-based classification of findings.
• Communicate audit outcomes to site management and relevant stakeholders, and review the adequacy of proposed corrections and corrective actions.
• Lead cross-functional audit teams by coordinating co-auditors, allocating audit topics and promoting consistent evidence collection and finding classification.
• Support auditor qualification, checklist development, audit learning and the ongoing effectiveness of the global audit program.

More about you

• A bachelor's degree or equivalent qualification in quality management, engineering, life sciences, medical technology, regulatory affairs or another relevant technical or scientific discipline.
• At least five years of experience in Quality Management Systems or regulatory affairs, ideally within the medical device industry, together with demonstrated auditing competence.
• Documented training in relevant standards and regulations, particularly ISO 13485, ISO 9001, MDSAP and the EU Medical Device Regulation, plus certified Lead Auditor training.
• Deep knowledge of core quality processes, including audits, CAPA, non-conformances and change control, combined with a risk-based and evidence-led approach.
• High integrity, independence and resilience, with strong analytical skills, attention to detail and the confidence to manage challenging audit situations.
• Clear and respectful communication, active listening, effective interviewing and strong facilitation and conflict-resolution skills in multicultural environments.
• Fluent business English, written and spoken; additional Portuguese or Spanish will add value
• Willingness to travel approximately 40% globally

More about what we offer

• We want to create an environment where you can balance a successful career with your commitments and interests outside of work, through our flexible hybrid working model. We offer a wide range of training opportunities for both your professional and personal development, and there are exceptional growth opportunities with individual development plans.

Sonova is an equal opportunity employer.

We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the market place. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate's ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.