Ireland- Assistant Quality Manager- ISO 13485 Medical Device- 11 months Contract- €35-€40 per hour- DOE Immediate Interview and Immediate Start,. My client is a highly reputed Medical Device business in Republic of Ireland. They run QMS accredited to ISO13485, and legislated/regulated to USFDA(21 CFR 820) and to EU MDD regulations. There is an immediate requirement for an experienced Senior Quality(Validation and Quality Engineering biased) Engineer to assume responsibility as a Assistant Quality Assurance Manager. The sought experience is prefered directly from Medical Device sector to substantiate the regulatory/compliance/legislative requirements. My understanding about the client requirement on which the Director of Quality will assess is as below x Quality Engineering experience to ISO 13485 QMS and applicable to EU MDDs x Validation of IQ,OQ,PQ and SQ - Essentially to ISO13485 and USFDA 21 CFR 820 + EU MDD x FMEAs P & D- Essentially to ISO13485 and USFDA 21 CFR 820 + EU MDD x SPC and Peformance Tools/Process -Essentially to ISO13485 and USFDA 21 CFR 820 + EU MDD xCAPAs, Investigation and Customer Management-Essentially to ISO13485 and USFDA 21 CFR 820 + EU MDD xImplementing the QMS and driving compliance- Essentially to ISO13485 and USFDA 21 CFR 820 + EU MDD This is a good opportunity for an experienced Quality Engineer from the Medical Device background looking for a long term contracting.