Quality and Compliance Specialist

We are currently recruiting for a Quality and Compliance Specialist for a world leading medical, surgical, life science, laboratory and pharmaceutical company for instrumentation & consumables. 

Duties and Responsibilities:

• Operation and development of the quality systems.

• Achievement of quality performance objectives.

• Ensuring the adherence of all activities to the requirements of our quality management systems.

• Working closely with individual managers and staff across the Company to proactively assist them in addressing non-conformances and enhancements to procedures in their area of responsibility.

• Fostering of a commercially orientated quality driven culture across the Company.

• Participation in internal and external audits and the risk management processes.

• Management of quality actions with customers and suppliers, this includes product recall and adverse event reporting processes.

• Ensuring adherence to the requirements of the Company’s Pharmaceutical Wholesaling License.

• Liaison with external regulatory bodies on all quality and regulatory related matters, in particular the Irish National Accreditation Board (INAB), Medicines and Healthcare Products Regulatory Agency (MHRA) and the Health Products Regulatory Authority (HPRA).

• Monitoring developments and changes and to quality related regulations and how they may affect the Company’s operations. Ensuring the Company’s compliance with all such regulations.

Required Qualifications/Experience:

• Degree or Diploma in Science/Engineering or QQI is desirable.

• Minimum 2 years’ industry experience in a similar role.

Preferred Experience (but all not essential).

• ISO 9001

• ISO 13485

• ISO 17025

• ISO27001