QMS Manager
We usually respond within two weeks
Driven by the passion to improve quality of people’s lives, WSA continues to grow as a market leader in the hearing aid industry. With our commitment to increase penetration in an underserved hearing care market, we want to accelerate our business transformation in order to reach more people, more effectively.
The QMS Manager contributes to the development and governance of the Corporate Quality Management System and implementation/ enrollment of such System across the organization. This role ensures that quality processes are aligned with global regulatory requirements and business objectives, enabling a culture of compliance, continuous improvement, and operational efficiency.
[a few high level lines to describe the mission of the role]
What you will do
- Development and governance of the Corporate Quality Management System, as well as its implementation and rollout across the organization.
- Ensuring that quality processes align with global regulatory requirements and business objectives, fostering a culture of compliance, continuous improvement, and operational efficiency.
- Planning and conducting internal and external audits to ensure compliance with regulatory and quality standards.
- Supporting change management initiatives across the Quality organization to ensure smooth transitions and alignment with strategic goals.
What you bring
Experience
- Experience managing QMS across multiple functions or sites. Strong knowledge of ISO 13485, FDA QSR, EU MDR, MDSAPExperience with QMS implementation or upgrades Strategic QMS planning and execution.
- Audit leadership and regulatory inspection readiness. Risk management and CAPA oversight.
- Quality metrics and performance reporting. Leadership and team management.
- Excellent stakeholder communication.
Personal competencies
- Minimum 4 years of experience in Quality Assurance within the medical device industry.
- Proven leadership in managing QMS frameworks across multiple sites or functions.
- Experience in leading audits (internal, external, notified body, FDA).
- Strong project management skills and ability to influence cross-functional teams.
- Experience in implementing or upgrading electronic QMS systems.
Who we are
At WSA, we provide innovative hearing aids and hearing health services.
Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world.
With us, you will become part of a truly global company where we care for one another, welcome diversity and celebrate our successes.
Sounds wonderful? We can't wait to hear from you.
WSA is an equal-opportunity employer and committed to creating an inclusive employee experience for all. Regardless of race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, disability, military or veteran status we firmly believe that our work is at its best when everyone feels free to be their most authentic self.
- Department
- Quality
- Role
- Group Quality - Quality Management System
- Locations
- Komorniki, Poland
Komorniki, Poland
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