Quality Systems Engineer II | Permanent | Galway.
Our client, a global leader in the Medical Device industry is looking for a Quality Systems Engineer II to join their team on a permanent basis.
You will provide quality engineering support within new product development, operational and/or systems/services support.
What you will be responsible for:
- You will be responsible for the implementation, co-ordination, and continuous review of the CAPA, Internal and Corporate Compliance programs.
- You are an expert in internal auditing techniques and is familiar with all regulatory requirements (e.g., FDA, ISO and MDD).
- You will act as an effective leader or team member in supporting quality disciplines, decisions, and practices.
- You will apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- You will drive changes in procedures and standards to facilitate work efficiency and to maintain quality.
- Familiar with the internal auditing system.
- You understand and proactively follow through on the Environmental Management Procedures that have been identified as relevant to position.
- You will act as a leader of quality, QSR and ISO/MDD standards within one’s own group, constantly promoting awareness of best industry practices, making appropriate decision on a daily basis utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decisions
- You will demonstrate a primary commitment to patient safety and product quality.
- You will ensure all direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.
What we need from you:
- NFQ level 8 (240 credits) in Science, Quality, or any other STEM discipline
- Minimum requirement 3 years in a Medical Device / Pharmaceutical environment, including practical experience of working within a highly regulated quality management system (QMS).
- Strong understanding and experience in the implementation of ISO 13485, ISO 14971, MDR.
- Accredited lead auditor against recognised quality standards in support of internal audits
- Must be able to organise and prioritise tasks, must be detail orientated and self-motivated.
What we can offer you:
- Comprehensive Benefits
- Life-Work Integration
- Career Growth
If you are interested in this position please apply with an updated CV to Rebecca O’Connor at ROconnor@sigmar.ie or call 091 749265 for more information.
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