Quality Control Manager
The position is essential for ensuring the quality of the new product developments and maintaining the existing products; to ensure adequate product documentation and product control, guaranteeing data integrity, ensuring software reliability, building trust, facilitating continuous improvement.
Role and Responsibilities:
- Assure high quality of our products throughout their entire lifecycle;
- Work close with R&D on new product developments and maintaining existing products – SaMD and non-medical Software
- Assure data accuracy and data integrity.
- Support product registrations.
- Complaint investigation in collaboration with R&D teams and customer support
- Lead or participate in Quality related project, where applicable
- Support to quality related processes, e.g. internal audits, supplier audits, external audits, CAPA management, training and others
Requirements and Education:
You hold a Bachelor’s or Master’s in engineering, computer science, life science or other related fields. Software background is a plus as well as a Lead Auditor certificate. You have a minimum of 5 years professional experience in new product development of medical devices, preferably SaMD; experience in quality management or regulatory affairs of medical devices, preferably in a Software environment.
Key Required Skills, Knowledge and Capabilities:
- Knowledge of MDR, CFR FDA, MDSAP, ISO 14971, ISO 13485, IEC 62304
- Good technical understanding of software
- Excellent communication and team player skills
- Independent and results-oriented way of working
- Fluency in English (written and spoken) – German is a plus
Do you feel like joining us? Please apply today!
Kontakt
Femke Kok Courant