Senior Quality Engineer

Our client is an innovative dental MedTech company. Their focus is on high-performance zirconia dental implants, combining cutting-edge materials science with biological dentistry concepts. With a strong international presence, their products are distributed globally, supporting modern, patient-centric dental treatments.

The role

In this position, you will join as a Senior Quality Engineer, taking ownership of key quality and regulatory activities within the organisation. You will play a central role in maintaining and improving the Quality Management System, while supporting product development, supplier quality, and compliance with global medical device regulations. This is a hands-on, high-impact role where you will help embed quality across the business and ensure the successful delivery of safe, compliant products.

Key responsibilities

• Lead quality and regulatory compliance activities, with a primary focus on quality engineering.
• Own validation and verification activities, including Computer System Validation (CSV).
• Conduct risk analyses and drive risk management processes across products and operations.
• Develop and manage inspection planning and quality control strategies.
• Drive supplier quality and supplier development initiatives.
• Support product development activities from a quality perspective.
• Manage CAPAs and non-conformities, ensuring effective resolution and continuous improvement.
• Plan and conduct internal and supplier audits, and support external audit preparation.
• Develop and deliver training related to quality processes and systems.
• Maintain and continuously improve the Quality Management System in line with ISO 13485, MDR, and MDSAP.
• Support key quality processes including change management, document control, CAPA, audits, and training.
• Assist in preparing regulatory documentation to ensure market approval and compliance.
• Contribute to technical and development documentation throughout the product lifecycle.
• Promote and embed a strong quality mindset across the organisation.

Required experience and qualifications

• Degree-qualified or equivalent experience, with several years of experience in a similar quality role.
• Strong experience within medical devices, ideally in a regulated environment.
• Proven expertise in validation/verification, risk management, CAPA, and audits.
• Experience working with ISO 13485, MDR, and/or MDSAP frameworks.
• High level of accuracy, reliability, and strong quality mindset.
• Structured, independent, and goal-oriented working style.
• Strong communication skills and ability to work cross-functionally.
• Fluent in both German and English (written and spoken).

Why this role?

• Join a fast-growing, innovative dental company at the forefront of ceramic implant technology.
• Work in a modern, collaborative environment with flat hierarchies and a strong team culture.
• Flexible working conditions, including home office options.
• Opportunity to shape quality processes in a scaling MedTech business.
• Access to employee wellness initiatives and company events.