Quality Assurance Manager
T: +44 (0) 28 9442 2413
Quality Assurance Manager – Randox Teoranta – (Job Ref: 21/QAMT)
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.
• Day to day management of QA/Regulatory Compliance at Randox Teoranta
• To take a pro-active approach to assuring quality throughout all site processes with an active role in 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
• Act as the Authorised Representative and Person Responsible for Regulatory Compliance for Randox Laboratories to comply with IVDR-Regulation 2017/746.
• Communicate with the HPRA, with regards to; Compliance, Product Registrations and Post Market Surveillance on behalf of Randox Laboratories
• 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
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
• Flexible approach and willingness to work outside hours when required.
• Previous staff management experience
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.
Randox is an equal opportunities employer.
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.
Is fostóir comhdheiseanna é Randox.