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 within our QA / Regulatory Affairs team.
Overview
Develop and implement policies to ensure compliance with National and International Quality Regulations and Harmonised Standards. Monitor and apply standards created or maintained by external bodies and integrate them within the internal quality management system. Proactively identify risk areas and implement process improvements.
Location
Randox Science Park, 30 Randalstown Road, Antrim, BT41 4FL.
Contract
Full-time, Permanent.
Working Hours
40 hours per week, Monday–Thursday 10-hour shifts.
Role Responsibilities
This role is responsible for conducting internal audits. The responsibilities include:
- Participating in external audits with Accreditation and Registered bodies.
- Conducting internal quality system audits.
- Reviewing the CAPA program and assisting with the implementation of preventative actions.
- Assisting in supplier audits and audits by accreditation bodies, registration bodies, and customers.
- Supporting staff with design verification, validation, risk management, and change control activities.
- Interpreting quality and compliance standards and assisting in the development of existing designs and processes to meet national and international standards.
Training
Full on-the-job training will be provided on our processes.
Essential Criteria
- Degree level education or demonstrated relevant experience of the Randox Quality Management System.
- Excellent communication skills with the ability to disseminate information concisely throughout the company.
Desirable Criteria
- Life science degree.
- Experience and working knowledge of ISO13485, MDSAP, and 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 role.
Randox Laboratories Limited is an Equal Opportunities Employer.
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