Quality Assurance Specialist
T: +44 (0) 28 9442 2413
Quality Assurance Specialist – (Job Ref: 21N/QASP)
We require an experienced and motivated Quality Engineer to work within the Quality Assurance Department based in Crumlin, County Antrim.
• To provide specialist regulatory support to design and development teams using a hands-on approach.
• Work closely with a wide variety of manufacturing teams to establish and maintain process that assure the quality of the product and processes provided.
• Develop strategies alongside the manufacturing teams and/or design teams to build upon and comply with established quality assurance procedures driving continuous improvement.
• Work with manufacturing teams to trouble shoot non-conformance through root cause analysis and drive improvement through the implementation and monitoring of corrective and preventive action arising from non-conformance.
• Provide quality assurance/regulatory compliance support at internal, regulatory, third party or customer audits.
• Training of staff in areas in which you are a subject matter expert, including regulatory compliance.
• Adherence to company Positive
• Educated to degree level in an Engineering or Science related discipline or relevant experience.
• Experience of working in a highly regulated industry to relevant quality requirements (e.g. ISO standards).
• Excellent IT and 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.
• Flexible approach and willingness to work outside hours if required.
• Experience in a quality role.
• Experience of working to medical industry standards e.g., ISO13485, IVDD 98/79/EC or IVDR.
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. 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.
Central to the Randox ethos is our drive to improve healthcare worldwide and every one of our staff plays a vital role in this aim.
Randox Laboratories Limited is an Equal Opportunities Employer