We have an opportunity with a global leader in transfusion diagnostics who are adding a Senior Manager for Quality Operations to the team in Frankfurt. The role supports the Sr. Director RA/QA. You will assist in improving and updating the QMS for complaint handling, and manage the product investigation lab where serological tests are conducted.
- Contributes to the quality oversight of IVD products according to ISO 13485, ISO 9001, IVDR, cGMP standards and applicable national laws and guidelines.
- You will oversee complaint investigations and report their outcomes.
- Supervises serological work performed by Product Surveillance/Quality Control Lab eg. various studies for IMD products.
- Works closely with Technical Support Supervisor/Manager to ensure timely completion of complaint testing and customer notification.
- Support product release by evaluation of release testing and sample submission to notified bodies.
- Maintenance of the Quality management system in the area of responsibility.
- Responsible as Deputy Person for Regulatory Compliance
- Bachelor's degree in chemistry, biology or other related scientific discipline.
- Experience in a blood donation centre - either laboratory of quality based.
- Experience in implementing ISO 9001, ISO 13485 and IVDR standards.
- Experience in IVD Product Study preferred.
- Fluent in German and English - spoken and written