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.
Responsibilities:
* 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.
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.
* 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.
#J-18808-Ljbffr