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23.09.2016

Director of Quality Assurance

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Medical Devices organization, based in Switzerland.

My client is a Medical Devices company that provides custom-made, high specification quality control materials for the periodic verification of the precision and accuracy of in vitro diagnostics (IVD) analyzers.

ROLE DESCRIPTION

Primary responsible person for the QA department, consisting of QA, RA and QC, you will provide leadership and management for Quality Assurance activities to ensure that Quality Systems and products are effective and in compliance with regulatory expectations and quality standards. You will lead at both strategic and operational levels.

RESPONSIBILITIES

- Ensure compliance to regulatory requirements including Quality Management Systems standards i.e. ISO 13485, FDA 21CFR820 and the EU In Vitro Diagnostics Directive (98/79/EC)
- Further develop and implement the quality management system culture within the company
- Ensure that all customer complaints are responded to within appropriate time frames and escalated appropriately through the vigilance process when required - Prepare and monitor site quality objectives and provide metrics and QA input to the Management Team
- Prepare the site for, and host, external audits (customer/regulatory) ensuring corrective/preventative actions are put in place to address non-conformances
- Ensure the quality and regulatory compliance of the facility is maintained through an effective monitoring program
- Review ongoing development of the Quality System to ensure and improve its effectiveness through ownership of the management review process
- Ensure that validation system is in compliance with relevant external (regulatory) requirements including ISO, QSR and IVDD
- Monitor process changes through the Change Management System, to ensure compliance
- Monitor product non-conformances for compliance
- To maintain awareness of new relevant regulatory requirements and to alert staff of required system and/or procedural changes
- Lead and develop staff within the area to a high level of competency

REQUIREMENTS

- Degree in a Biological Science
- 7 - 10 years of management experience in Quality Assurance
- Knowledge of regulatory requirements, including ISO 13485 and the EU IVD Directive, 21CFR 820
- The position requires a hard-working, ambitious and creative individual, with strong analytical and communication skills
- Excellent written communication skills in both German and English

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Matthias Kunkel.



 
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