Beschreibung
To join a Medical Device company to Join the Quality Management team as a Junior Quality Manager CSV in Swizterland - Basel.Your tasks
- Responsible for the validation projects in connection with computerized systems (CSV)
- Support in the preparation of SOPs according to ISO 13485
- Independent and responsible planning, implementation,
- Participation in the area of quality management
- Support in the evaluation of error messages
- Implementation of qualification/validation activities of new and existing computer systems and software
- Validated computer systems during their entire life cycle maintained in the validated state
- Participation in the organization and implementation of recertification and surveillance audits as well as internal and external audits
Your profile
- Technical, biotechnological or scientific education at FH or similar level, with first experience in CSV validations and Quality Management
- Knowledge of CSV methods, V-Model, GAMP, 21 CFR Part 11, ISO
- Knowledge of ISO 13485, IVDR, MDR is advantageous
- High quality awareness and good communication skills
- Fluent German and English written and spoken
Michael Bailey International is acting as an Employment Agency in relation to this vacancy.