- Eysins, Switzerland
Building on 30 years of experience in transfusion diagnostics, Quotient is a commercial-stage diagnostics company committed to delivering solutions that reshape the way diagnostics is practiced. MosaiQ™, Quotient’s proprietary multiplex microarray technology, offers the world’s first fully automated, consolidated testing platform, allowing for multiple tests across different modalities. MosaiQ™ is designed to be a game-changing solution, which Quotient believes will increase
efficiencies, improve clinical practice, deliver significant workflow improvements and operational cost savings to laboratories around the world. Quotient’s operations are based in Eysins/Switzerland, Edinburgh/Scotland and Newtown/Pennsylvania.
Support Notified Body, Health Authority audits and CE marking submissions
Support Documentation Control, Non-conformance, CAPA and Change Control
Ensure that incidents, deviations and quality system requirements are captured and reported
Support eQMS implementation
Prepare and maintain documentations related to materials and suppliers in accordance with EN ISO 13485, 21 CFR Part 820, IVD and FDA regulations.
Conduct audits in support of the internal and external audit program
Contribute to the design and implementation of new quality systems and procedures
Participate in an “in-house” program of continuous training, assessment and write internal training presentations
Relevant Bachelor/Master degree in science (Pharmaceutical/Biotechnologies) or equivalent
Work experience in a GMP environment, GMP auditing and CSV an asset
Working knowledge of ISO 13485:2012, 98/97/EC requirements, IVD directives and FDA Code of Federal Regulations knowledge.
Ability to analyses information in a structured manner and be able to prepare coherent reports
Proactive, explicit attention to details, good organisational
Strong customer focus and team player skills
Good communication skills and ability to demonstrate a collaborative approach
Fluent in English and French an asset