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Quality Assurance Manager

RandoxDungloe, Donegal
We require an experienced and motivated Quality Assurance Manager to lead the Quality Assurance Department based at the Randox Teoranta site in Dungloe, County Donegal. The successful applicant will have overall responsibility for quality assurance across this site. 


The Role:

• Day to day management of QA/Regulatory Compliance.
• To take a pro-active approach to assuring quality, risk mitigation and continuous improvement.
• Establish Quality Initiatives based on the Quality Objectives with a view to improving quality
• Manage internal audit schedule; this includes performing internal audits, reporting results
• Participation in Regulatory, Third Party and Customer inspections and completion of follow up activities
• Management of non-conformance process with responsibility for implementing robust corrective and preventative actions


Essential Skills:

• Educated to degree level in a Science/Engineering related discipline and one year’s professional experience in a Quality Management System or regulatory affairs role relating to In vitro diagnostic medical devices

Or 

Four years professional experience in a Quality Management System or regulatory affairs role relating to In vitro diagnostic medical devices 
• Experience of ISO 13485 Medical Devices quality standard and In Vitro Diagnostic Regulation (IVDR)
• Experience in leading continuous improvement initiatives and developing team members to adopt key principles
• Excellent communication skills (verbal and written) and ability to communicate information in a concise manner 
• Excellent leadership skills and a high level of self-motivation 
• Ability to work methodically and reliably under pressure


As a Gaeltacht employer Randox encourages applications from Irish speakers.

Randox Laboratories is passionate about improving global health and saving lives through the development of innovative and pioneering products. Through our commitment and the skill of our people we have grown to be a world leader in diagnostics for clinical healthcare, toxicology, food security and providing quality solutions to over 145 countries. In order to serve our growing international markets we require high calibre applicants with scientific, engineering, software and broader business skills – including sales, marketing, logistics, finance and many more.
Randox is an equal opportunities employer.
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Siocair gur fostóir Gaeltachta é Randox, spreagtar iarratais ó chainteoirí Gaeilge.

Tá Saotharlanna Randox díocasach fá sláinte an domhain a bhisiú agus beatha daoine a shábháil a bhuíochas de tháirgí nuálacha agus ceannródaíochta a fhorbairt. De bharr ár dtiomantas agus scil ár ndaoine, táimid anois inár gceannairí domhanda i ndiagnóisic do chúram sláinte cliniciúil, saineolaíocht, slándáil bia agus ag cur ar fáil réiteach den chéad scoth do níos mó ná 145 tír. Chun freastal ar ár margaí idirnáisiúnta atá ag fás tá iarratsóirí den scóth de dhíth orainn, daoine a bhfuil scileanna eolaíocha, innealtóireachta, bog earraí agus scileanna gnó níos leithne acu – ar a n-áirítear díolacháin, margaíocht, loigisticiúil, airgeadais agus go leor eile.
Tá ár dtiomantas chun cúram sláinte a fheabhsú ar fud an domhain lárnach do mheon Randox agus tá ról ríthábhachtach ag gach duine dár bhfoireann san sprioc seo.
Is fostóir comhdheiseanna é Randox.

The closing date for applications is Monday the 29th of November 2021

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