Quality Assurance Specialist
1 week ago
About ASI:
Applied Spectral Imaging (ASI) is a global leader in biomedical imaging, offering a comprehensive product portfolio for Karyotyping, H&E, IHC, and FISH analysis. We provide Pathology, Cytogenetics, and Research laboratories with advanced imaging and analysis tools.
Main tasks and responsibilities:
Further development and monitoring of the Quality Management System (QMS) according to ISO 9001, ISO 13485, MDSAP and IVDR
Carrying out internal audits and management reviews to ensure quality
Processing and monitoring of deviations, corrective and preventive actions (CAPA), changes and complaints
Processing of supplier qualification
Training staff on quality standards and procedures
Internal consultation on QMS issues
Liaising with other departments to ensure product quality
collaboration in projects representing QA, partial project management depending on project
Qualification requirements:
Degree in a relevant field (e.g. engineering, IT, science)
professional experience in quality management/quality assurance, ideally in the filed of ISO13485 and IVDR, is an advantage
Knowledge of MDSAP and internal auditing desirable
Strong analytical and problem solving skills
Personal Skills
· Motivated and Diligent
· Assertive and Proactive
· Fast learner with 'can do' approach
· Communicative and team player
· Efficient and Effective approach
·· Ability to work in a dynamic environment
Why Join ASI?
At ASI, you'll be part of a team driving innovation in biomedical imaging, with the opportunity to make a significant impact in Pathology, Cytogenetics, and Research laboratories worldwide.
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