Exciting Opportunity for an Experienced Quality and Validation Specialist in Bern, Switzerland
Our client, an established Medical Device company located in Bern, Switzerland, is seeking a highly skilled Quality and Validation Specialist to join their dynamic team. The successful candidate will play a pivotal role in ensuring that the validation processes are compliant with ISO 13485 standards. This is an exciting opportunity for a candidate who is passionate about the Medical Devices sector and is seeking a challenging role to further their career.
Responsibilities for this position include:
- Working across multiple tasks within the growing Quality team
- Supporting site production, operations, and quality teams.
- Serving as the quality representative during any product or process investigation and during external and internal audits.
- Preparing and executing validations, technical studies, test method validations, and other studies/reports.
- Initiating and leading project teams on Corrective Action/Preventive Action (CAPA) projects.
- Interfacing with external auditors (notified body) and participating in the preparation and completion of corrective action plans.
- Performing risk analysis, determining root cause, and recommending corrective action.
Requirements for this position include:
- A bachelor's degree in quality, mechanical, life sciences, or industrial engineering.
- Minimum five years' experience or advanced degree with three years of experience in quality engineering, in the medical device or pharmaceutical industries.
- Several years' experience in Validation.
- Proficient IT Skills.
- Very flexible and adaptable to change with ability to work under pressure.
- Responsible, team-oriented, and well-organized personality.
- Excellent English skills, both spoken and written.
- In addition to a competitive salary, our client is also offering flexible hybrid work options.
- The successful candidate will be provided with ample opportunities for professional development, including training and mentoring programs. Our client is committed to creating a positive and inclusive work environment that fosters teamwork, collaboration, and innovation.