FASTBASE Solutions is a biotechnology company situated in the Basque Country that has developed a patented technology, QF-Pro®, which quantifies protein-protein interactions and protein post-translational modifications in single cell and fixed tissue samples, with a wide array of applications in the fields of pharmacodynamics, precision diagnostics and prognostics.
Details:
Location: Derio, Vizcaya/Bizkaia (Spain)
Work modality: Hybrid (Face-to-face and telecommuting)
Experience: 1 year minimum
Contract Type: Indefinite, part-time
Other: Flexible hours
Description and Responsibilities:
FASTBASE are seeking to employ a person to cover the functions and responsibilities of a quality control manager in a medical device manufacturing company. We require the following experience:
- Implementation and maintenance of quality management systems (ISO9001 or, preferably, ISO 13485), internal, external and supplier audits.
- Data collection, monitoring of indicators and quality objectives.
- Comprehensive preparation of a Quality Manual.
- Training of company staff in quality matters
- Certification of medical devices (CE IVD-R marking), management of necessary technical dossiers and documentary processes in license applications.
- Interaction with competent authorities, management of claims, non-conformities and CAPAs.
- Internal auditor certificate (valuable)
- Experience in implementation and management of LMS (Laboratory Management Systems) (valuable)
We are seeking an energetic person, with good organisational skills, comprehensive IT skills, a sound level of English (essential) and fantastic oral and written communication skills.
To apply, please send your CV to contact@fastbasesolutions.com
