Quality Assurance Specialist

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.