CAScination AG, Switzerland is a fast-growing and award-winning medical technology company dedicated to the development, manufacturing and commercialization of innovations in computer-assisted and image-guided surgery. Our mission is to improve medical interventions by establishing robotics and navigation technology as standard of care. Our products enable doctors to perform highly precious, reproducible and efficient treatments and give patients access to minimally invasive and effective therapies. Our CAS-One planning and navigation system is used to treat patients suffering from soft tissue cancer (e.g., liver cancer) by many hospitals across Europe and Asia.
We are looking for a mastermind to become our:
In this position you are responsible for all production related verification and validation planning activities and the development of the verification and validation standard operation procedure.
- Create and maintain the site Master Validation Plan
- Development of validation protocols (IQ, OQ, PQ)
- Collate all data associated with a validation (IQ, OQ, PQ) and compile the final validation report for approval
- Maintain all validation documentation in accordance with site Quality System Requirements
- Verify that that validation studies have been adequately recorded and documented in accordance with the approved Master Validation Plan(s) and Validation Protocols
- Ensure that all deviations to protocols and/or deviations to acceptance criteria are adequately controlled, documented and addressed
- Ensure that the validated state is maintained
- As a Validation Engineer you will be responsible for all relevant Process / Equipment Validation activities
- Review of the impact of change on the maintenance of the validated state, including execution of re-validation as required
- Periodic review of documentation management system workflows to ensure both regulatory & business needs are satisfied
- You will also be expected to contribute to other QA activities such as: NC/CAPA management, Supplier Management, Change Control
Contact us if you are
- You are an energetic person with a clear attitude towards progress and success
- 3-5 years of validation experience in a medical device manufacturing environment
- Bachelor’s degree in Engineering, Manufacturing or related field preferred
- You are very systematic and have a highly developed common sense
- You are comfortable in independent decision making
- Knowledge of medical device regulations and standards such as ISO 13485, GMP 21 CFR, MDR, ISO (production FMEA)
- Knowledge of statistical techniques, Minitab user knowledge a distinct advantage
- The ideal candidate will possess excellent planning and coordination skills and be able to readily adapt to changes in priorities and project schedules
- Proficient in English, German is a plus
We offer you a challenging role in a multinational and innovative environment, participation in a rapidly growing company and personal development to shape and realize your career goals.
We look forward receiving your application including CV, Motivation Letter, Working References, Diploma via email to email@example.com) (Applications from recruitment agencies will not be considered).
For questions, please contact: Léonie Bernet, +41 31 552 04 30