2 days ago
Full-time
Mid Level
#gesundheitsanwendungen #kI-Forschung#digitalmedizin
Quality Manager (f/m/x) at PINK!
Discover 32 Jobs like this
Create an account and we will automatically match you with the most relevant job opportunities.
This text was automatically summarized
Intro
As a Quality Manager (f/m/x) at PINK!, you will be responsible for the implementation, monitoring and continuous improvement of our quality management system, ensuring that our products meet the highest standards and fulfill all legal requirements.
Tasks
- Implementation, monitoring and continuous improvement of the quality management system
- Ensuring compliance with relevant laws, guidelines and standards
- Implementation and maintenance of QM standards, processes and new regulatory requirements
- Reviewing and creating regulatory process instructions (SOPs)
- Communicating with authorities
- Support in the preparation of documents for market authorisation of Class I software medical devices
- Coordination of corrective and preventive actions (CAPA)
- Responsibility for risk management and change control
Requirements
- Degree in quality management, engineering, medical technology or comparable qualification
- Sound knowledge of ISO 13485, IEC 62304 standards and regulatory requirements for medical devices
- Experience in risk management, CAPA processes and quality audits
- Strong communication skills and experience in liaising with authorities
- Ability to train employees in quality topics
- Fluent written and spoken in German and English
- Nice to have: Experience with breast cancer
Benefits
- Part of a team creating innovative solutions for oncological patients
- Flat hierarchies allowing independence and creativity
- Dynamic and diverse team with positive interaction
- Flexible working hours
- Equal Opportunity Employer
2 days ago
Mention baito
You like what we are doing? You can support us by mentioning that you found this job on baito.