Quality Compliance Officer — Audit & Quality Systems Lead

Randox Laboratories; Randalstown; À distance; GBP 35 000 - 52 000; Plein temps

Résumé du poste

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.

Qualifications

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

Responsabilités

• 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.

Connaissances

Excellent communication

Attention to detail

Quality mindset

Formation

Bachelor's degree in Life Science or related field

Outils

ISO13485

MDSAP

IVDR 2017/746

Description du poste

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.