Device Documentation Specialist (Job Ref: 25N/DVDD) Randox Laboratories continues to develop disruptive innovations within the Diagnostics and Healthcare sector globally. We are proud to have been named the Number 1 company in Northern Ireland, for the second consecutive year in the Belfast Telegraph Top 100 Companies 2024. Our staff are at the heart of everything we do and achieve. We have an exciting career opportunity for a Device Documentation Specialist within our Quality Assurance team. Location: Randox Science Park, 30 Randalstown Rd, Antrim BT41 4FL. Contract Offered: Full-time, Permanent. Working Hours / Shifts: 40 hours per week. There are options available to work 10 hour days from Monday to Thursday or 9 hour days Monday to Thursday and 4 hours on a Friday. What does this role involve? This role is responsible for the risk management files for all Randox products. Some of the main duties include: Periodic review, revision and reissuing of Risk Management documentation for Randox products. Review, revision and reissuing of Risk Management documentation for Randox products following design change, purchasing change,new hazards identified following post market surveillance, CAPA completion and vigilance reports. Attendance and contribution at technical support, design change, Non -conforming Product/ Process and Post market surveillance meetings. Periodic review and update of Safety data sheets for Randox products forecast related enquiries and issues. Assisting in external & internal quality system audits. Provide support when required and ensure that customers, distributor and OEM partners are serviced at the highest level of satisfaction through quality service and quick responses. The promotion of quality awareness throughout the company. Who can apply? Essential criteria: Educated to Degree level or possess relevant experience in a similar role. Strong IT skills including Word, Excel, PowerPoint, Microsoft Outlook. Experience with interpretation of technical information and performance data. Previous experience within an office environment. Desirable: Life Science degree. Previous experience in a similar role. Knowledge or experience in Quality Systems This advert may be open for as long as 30 days although we may close the advert early if we receive sufficient applicants to fill the roles. About Randox: An international company operating in over 145 countries that continues to have unparalleled growth, Randox Laboratories was at the centre of the UKs National COVID Testing Programme throughout the pandemic. In early 2020 Randox recognised the threat from COVID-19 and, based on over 40 years of diagnostic experience, quickly developed a test to accurately identify the virus. Testing at scale commenced within weeks to support the UKs National Testing Programme and private clients alike. Additionally, as a world leader in diagnostics for clinical healthcare, toxicology and food security, our expertise and product portfolio have assisted laboratories across the world in improving health and saving lives. Our global success is a result of our pioneering products and the commitment & skill of our workforce, which continue to grow exponentially. Central to the Randox ethos is our drive and determination to improve healthcare worldwide and every one of our talented staff play a role in this. 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. Join the Randox team and play your part in improving the health of millions. Randox Laboratories Limited is an Equal Opportunities Employer.