Randox Laboratories continues to develop disruptive innovations in Diagnostics and Healthcare 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 List for 2024. Our staff are at the heart of everything we do and achieve. We have exciting new career opportunities for a Quality Compliance Officer Team Lead within our QA / Regulatory Affairs team.
What does the QA / Regulatory Affairs team do?
Develop and implement Policies to ensure compliance with National and International Quality Regulations and Harmonised Standards.Monitor and inform/communicate/apply standards created/maintained by external bodies and integrate within the internal quality management system. To proactively seek risk areas & implement process improvements accordingly
Location: Randox Science Park, 30 Randalstown Road, Antrim, BT41 4FL.
Contract Offered: Full-time, Permanent.
Working Hours / Shifts: 40 hours per week, Monday to Friday from 08.40 to 17.20.
What does the Quality Compliance Officer role involve?
This role is responsible for conducting internal audits. This is a varied role that will require you to develop a varied skillset, including:
- To participate in external audits with Accreditation and Registered bodies.
- Conduct internal quality system audits.
- Review the CAPA program and the assistance with the implementation of preventative actions.
- Assist the performance of supplier audits and assist with accreditation body, registration body, and customer audits.
- Support staff with design verification, validation, risk management, and change control activity.
- Interpretation of quality and compliance standards, assist in the development of existing designs and processes and compliance with National and International standards.
Full on the job training will be provided on our processes.
Who can apply?
Essential:
- This role would suit someone educated to degree level or with demonstrated relevant experience of the Randox Quality Management System
- Excellent communication skills with the ability to disseminate information in a concise manner throughout the company.
Desirable:
- Life science degree.
- Experience with and a working knowledge of the ISO13485, MDSAP and the IVDR 2017/746 requirements.
- Experience in developing and conducting process validation studies.
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 has been the heartbeat of the UK's 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 UK's 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.