QMS Lead Auditor

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

As one of the world's leading hearing care providers headquartered in Switzerland, we're committed to building an inclusive culture. 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.

For this vacancy only direct applications will be considered.