A successful swiss creator to improve early detection of chronic lung diseases.
- You maintain and continuously improve our quality management system, ensure compliance with applicable regulations (e.g. MDR, MDSAP). Furthermore, you collect, analyze and evaluate post-market surveillance data and ensure information sharing between stakeholders.
- You support our process owners/teams to establish and improve and apply assigned processes.
- As a proactive partner you collaborate with key internal stakeholders and support the QM user community to achieve and establish KPIs for an effective process management.
- You provide trainings on the QM system for all employees (onboardings / continuous improvement process).
- You manage CAPAs, NCMs and SCARs, assess vigilance, and initiate potential reporting. Furthermore, you are responsible for internal and external audits. You support the definition and implementation of remedial action and promote trending activities.
- You are responsible to compile and maintain clinical evaluation reports.
- You lead quality and clinical affairs projects, represent respective matters in multidisciplinary teams.
The ideal candidate:
- A bachelor's degree in Life sciences (or similar) and preferably experience in quality management in a medical devices industry with expertise in Clinical Affairs
- Strong knowledge of the global regulatory environment
- Experience in working in a multinational environment within the medical devices industry
- Excellent English- and German-Language skills (min. C1)
- Analytical thinking and scientific documentation skills; strong communication, organization and tracking skills
- Proficiency in MS Office and other relevant computer systems
- CV an: firstname.lastname@example.org
- Phone call and discussion of the job opportunity.
- Guidance through whole interview process and possible discussion of other opportunities.