QMS Lead Auditor

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.

• 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.

• 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…