Quality Assurance Specialist
Job Summary
We are seeking a highly skilled Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring the quality of our products and services, while also contributing to the development of our quality management system.
About the Role
The main tasks of this role include:
* Leading new product introduction projects, focusing on qualifications and validations.
* Coordinating and managing CAPA projects to ensure compliance with regulatory requirements.
* Handling customer complaints, supplier issues, and internal deviations in accordance with GMP guidelines.
* Processing change requests related to process and document changes.
* Conducting supplier audits and internal audits to ensure compliance with ISO 13485 standards.
* Maintaining and continuously improving the quality management system.
* Reviewing and approving batch documentation.
* Monitoring Key Performance Indicators (KPIs).
Requirements
To be successful in this role, you will need:
* A degree in Mechanical Engineering, Medical Technology, or a related field.
* Experience in quality management, preferably in an industrial environment, with good knowledge of ISO 13485.
* A careful, reliable, and responsible working style.
* A solution-oriented and assertive personality with a high level of commitment.
* Fluency in English, with German or French as a mother tongue.
What We Offer
We offer a competitive package, including:
* Six weeks of vacation per year.
This is a challenging and rewarding role that requires a strong work ethic and attention to detail. If you are passionate about quality assurance and have the necessary skills and experience, we encourage you to apply.