This global healthcare company is committed to improving the health and well being 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 primarily operates in multiple divisions including Pharmaceuticals, Medical Devices and Diagnostics.

Within its Diagnostics Division, significant investment is being undertaken in its operation in the West of Ireland. There is a growing Quality operation being developed here due to legal transfer and global harmonisation projects. An opportunity has arisen for a Quality Systems Engineer to join this dynamic team.

You will be responsible for implementing, and maintaining the quality management system, and ensuring effective compliance in accordance with Quality & Regulatory, quality system and regulatory requirements.

The Position

• 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 standardisation and collaboration.
• Owning and completing CAPAs in Agile PLM.
• Authoring and maintaining procedures, work instructions, forms, and templates to ensure that processes are compliant with Corporate policies, external quality standards/regulatory requirements and customer (Entity) requirements.
• Support other QMS activities as required.
• Communicate confidently and effectively with all levels of management, peers and key stakeholders, including timely escalation of quality issues.
• Execute and provide on-time completion of Quality Assurance deliverables.
• Provide support and subject matter expertise during audits and inspections.
• Lead and/or contribute to continuous improvement initiatives and projects.
• Responsible for exhibiting professional behaviour with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.

The Person

• Bachelor's degree/master's degree in a science or technical discipline.
• 3+ years' experience in a Quality Assurance/Systems engineer role within a relevant regulated industry plus demonstrated competence.
• Detailed knowledge of FDA QSR (21 CFR Part 820), GMP, MDSAP, IVDR and ISO 13485.
• Solid communication and interpersonal skills.
• Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.

To discover more about this opportunity, apply now or contact Melissa Caramante in HRM on +353 87692 3026 for a confidential discussion.