26N/QCCO - Quality Compliance Officer

Randox Laboratories; Randalstown; Presencial; GBP 35 000 - 52 000; Tempo integral

Resumo da oferta

Randox Laboratories, located at Randox Science Park in Antrim, is seeking a Quality Compliance Officer to join the Quality Assurance team. The role emphasizes audits, CAPA review, and driving regulatory compliance in a fast-paced diagnostics setting.

You will conduct internal audits, participate in external audits, support supplier assessments, and help ensure compliance with ISO13485, MDSAP, and IVDR requirements across the organisation.

Qualificações

• Excellent communication skills with the ability to disseminate information concisely.
• Educated to degree level.
• Strong attention to detail.

Responsabilidades

• Participate in external audits with Accreditation and Registered bodies.
• Conduct internal quality system audits.
• Review the CAPA program and assist with preventative actions.
• Assist with supplier audits and 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.

Conhecimentos

Excellent communication

Attention to detail

Quality mindset

Formação académica

Bachelor's degree in Life Science or related field

Ferramentas

ISO13485

MDSAP

IVDR 2017/746

Descrição da oferta de emprego

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

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 Quality assurance team.

What does the Quality Assurance 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, 7am to 5.40pm or 8am to 6.40pm.

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.

Who can apply?

Essential criteria:

• Excellent communication skills with the ability to disseminate information in a concise manner throughout the company.
• Educated to degree level.
• Strong attention to detail skills.

Desirable:

• Life science degree.
• Experience working within a quality environment.
• 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.