This global healthcare company is committed to improving the health and wellbeing of people all over the world by developing, producing, and providing innovative healthcare services and solutions in more than 110 countries. With more than 80,000 employees globally, and over $40 billion in revenue per annum, this business operates in multiple divisions including Pharmaceuticals, Medical Devices and Diagnostics, primarily.

Within it's Diagnostics Division, there is significant investment at present, being undertaken in their operation in the West of Ireland and as such they are seeking experience Senior Quality Engineers to support with the QMS Harmonisation as well as the Design Transfer.

The Position

Key Responsibilties include:

• Carries out duties in compliance with established business policies and procedures.

• Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.

• Remains current with regulations and standards.

• Support the continuous improvement of quality system processes.

• Assist in the preparation and maintenance of records associated with the management review process including metrics.

• Apply problem-solving skills in order to deal creatively with moderately complex situations, work that typically requires processing and interpreting, more complex, less clearly defined issues. Identifies problems and possible solutions and takes appropriate action to resolve them.

• Drive compliance cross functionally in alignment with the Business Unit objective for standardization and collaboration.

• Owning and completing CAPAs in Agile PLM.

The Person

• 5+ years' experience in QA / Systems Engineer role within Med Device industry.

• Min BA Degree in science or a related technical discipline.

• Detailed knowledge of FDA QSR (21 CFR Part 820), GMP, MDSAP, IVDR and ISO 13485.

• Proven project management and leadership skills.

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To discover more about this opportunity, apply now or contact Deanna Healy in HRM Search Partners on + 087 6369263.