Beschreibung
Reference No.: 917007SRRole: Quality Assurance Manager/CAPA/FMEA/ISO 13485/FDA
Location:Lucerne and the region, Switzerland
Workload: 100%
Start Date: 01.01.2018
Duration: 31.03.2018
Project:
As Quality Assurance Manager you support Operations in order to achieve sustainable compliance with medical device regulations in the production of market products (Bloodgas & Electrolytes) as well as you are responsible for the following tasks:
- Conducting Quality Reviews for change management, deviation management and CAPAs
- Reviewing and releasing specifications as well as verification documents
- Participating actively in knowledge management as well as contributing to continuous process improvement initiatives
- Reviewing Device History Records and releasing products
- Quality representative for FMEA
Requirements:
- Bachelor of science in a technical field, advanced degree is a plus
- Solid professional experience in a regulated environment (ISO 13485 and regulatory requirements of United States FDA)
- SAP-knowledge
Languages:
- German mother tongue or very good
- English good
About us:
ITech Consult AG is a certified ISO 9001 : 2008 Swiss company with offices also located in Germany, Great Britain and Ireland. ITech Consult is specialised in delivering ICT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.
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