Warszawa, Poland
Manager Global QMS
As our Global Quality Management System (QMS) Manager, you will play a key role in maintaining and continuously improving Sonova's global Quality Management System. Working across regions and functions, you'll collaborate with Quality, Regulatory Affairs, Design Quality and Operations teams to ensure our quality processes remain robust, compliant and effective.
In return for your expertise in quality management and your collaborative approach, you'll join an international organization where your work directly supports regulatory excellence, operational performance and continuous improvement. This is an opportunity to influence global quality standards while helping deliver innovative hearing care solutions that improve people's lives.
More about the role
- Support the implementation, maintenance and continuous improvement of Sonova's global Quality Management System, ensuring alignment with regulatory requirements and business objectives.
- Drive consistent execution of core QMS processes, including CAPA, non-conformities, document control, change control, audits, training and management review.
- Monitor QMS performance through quality metrics, identify opportunities for improvement and support initiatives that enhance compliance and operational effectiveness.
- Collaborate with global process owners and regional quality teams to harmonize processes and ensure consistent implementation across the organization.
- Support regulatory inspections and internal audits by ensuring inspection readiness, accurate documentation and effective follow-up of corrective and preventive actions.
- Provide guidance, communication and training to stakeholders, promoting best practices and fostering a strong quality culture throughout the business.
- Monitor evolving regulatory requirements and contribute to the continuous development of the global quality framework.
More about you
- Bachelor's degree in Engineering, Life Sciences, Quality Management or a related discipline. A Master's degree is an advantage.
- At least 5 years' experience in Quality within a regulated industry, ideally medical devices, with proven experience supporting or managing Quality Management Systems in a global environment.
- Strong knowledge of international quality and regulatory standards, including ISO 13485, MDR/IVDR, FDA 21 CFR Part 820, GMP/GDP and MDSAP.
- Experience supporting regulatory inspections, quality governance and continuous improvement initiatives across global organizations.
- Excellent analytical, problem-solving and organizational skills, with the ability to simplify complex processes and drive effective solutions.
- Strong communication and stakeholder management skills, with the ability to collaborate and influence across functions, cultures and regions.
- Internal Auditor or other Quality Management certifications.
- Fluent in English; additional language skills such as German or Spanish are advantageous.
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.