Quality Compliance Officer

Quality Compliance Officer – (Job Ref: 26N/QCOL)

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 Quality Compliance Officers 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 – Thursday 10 hours shifts .

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.

Essential criteria:

• 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.