The succesfull candidate will improve operations by bringing systematic and disciplined approach to risk management, control and governance processes. A thorough knowledge of ISO 13485 and FDA QSR are required.
Quality Assurance Manager
Our client markets globally diagnostic devices, monitoring and emergency care solutions.
- Maintain and continuously improve the site quality management system to ensure compliance with all applicable regulatory requirements.
- Risk process accountabilities including process document update according to regulatory requirements.
- Responsible for risk assessment and related complaints.
- Manage CAPA process.
- Internal and external audits (including supplier audit).
- Review and approval of non-conformances, change controls, validation documentation.
- Manage and review Design History File for the assigned device groups.
- Contact person for interaction with relevant authorities contact person for vigilance reporting and safety and corrective action.
- Actively involved in quality projects.
- Life Sciences degree or equivalent.
- Proven track record in risk management.
- A minimum of 2 years in a medical device company / Quality assurance.
- Proven track record in auditing standards and regulations and ISO 14971.
- Strong organizational skills. Ability to multitask.
- Fluent in English and German.
Help people around the globe leading a healthier life
Join a growing player in the Medical Devices arena
Competitive Salary Package
Michael Page Switzerland