Quality Engineer
Kreuzlingen
Negotiable
PR/576894_1769518913
Quality Engineer
We are currently partnering with a market‑leading MedTech company specializing that is seeking an experienced Quality Engineer to join their team in Switzerland. This is an exciting opportunity to build a long‑term career with an innovative medical equipment manufacturers in the industry.
You will be responsible for:
- Performing all activities in the areas of Quality and Regulatory Compliance, with a primary focus on Quality.
- Leading validation and verification activities, including CSV.
- Conducting risk analyses and driving ongoing risk management.
- Managing inspection planning and ensuring testing processes are in place.
- Overseeing supplier development and qualification.
- Supporting product development activities from a quality perspective.
- Processing and executing CAPAs and nonconformities.
- Conducting internal audits, supplier audits, and preparing documentation for external audits.
- Creating and delivering quality‑related training.
- Maintaining and further developing the Quality Management System in accordance with ISO 13485, MDSAP, and MDR.
- Supporting key processes including change management, document control, CAPA, audits, and training.
- Contributing to the creation and maintenance of regulatory documentation needed to ensure market approval of products and services.
- Supporting the development of technical and development‑related documentation.
- Promoting quality management awareness throughout daily operations.
An ideal candidate should have the following qualifications:
- Completed degree with several years of professional experience, or several years of experience in a comparable role.
- Strong reliability, accuracy, and a high degree of quality awareness.
- A structured, independent, and goal‑oriented working style.
- Excellent communication skills.
- Ability to work both independently and collaboratively as part of a team.
- Excellent German skills (spoken and written).
- Excellent English skills (spoken and written).
- Proficient in MS Office and experienced with standard quality management tools.
What We Offer:
- A modern, technologically advanced, and inspiring work environment.
- A collegial team culture with flat hierarchies.
- A secure position with flexible working conditions and home‑office options.
