Quality Engineer

  • Eysins, Switzerland
  • Full-time

Company Description

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.

Job Description

  • 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

Qualifications

  • 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