Lead Quality Engineer with Internal & External auditor experience required for permanent role in Galway city
- Contributes to defining and timely achievement of overall project goals.
- Provides compliant solutions to a variety of problems of moderate scope and complexity.
- Interacts constructively with employees, managers and cross-functional peers.
- May lead a project with a limited scope, but usually a contributor on broader projects.
- Provides guidance to other Professionals and Technicians. Leading/supporting customer and regularity audits.
- Quality System Compliance: Maintains awareness of standards that regulate our industry. Ensures compliance to site level policies and procedures by promptly report and process non-compliant issues within the business as appropriate. Maintains vigilance to ensure adherence to Quality Policy and Quality system.
- Risk Management: Applies a high degree of Risk Management principles, methods and tools to work. Coordinates quality decisions between different quality and engineering groups. Participates in the development or modification of validation packages, design plans, and risk management deliverables (e.g. FMEAs). Team member helping and interfacing with suppliers to deliver product meeting our quality requirements.
- Problem Solving: Proven ability to successfully use structured problem solving methods for process improvement and data driven decisions. Recommends/implements possible solutions.
- Soft Skills: Has proven ability to be a key influencer and leader within projects and cross functional teams. Always speaks up to offer opinion in order to make things better. Displays good judgement and communicates well with peers and senior management.
- Complaint Evaluation: Investigates complex complaints with management oversight. Provides compliant solutions to a variety of complex problems.
- Design Control/Documentation & Change Control: Identifies areas for process improvement. Provides supporting information for change including reasons and justifications.
- QQI LEVEL 7 in Quality, Life Science, Engineering, or closely related discipline is required.
- At least 3 years work experience in Quality or related field experience; Less experience may be appropriate with advanced degree.
- Demonstrates understanding of how their function supports the business.
- Demonstrates technical and business competencies that drive results and continuous improvement.
- Internal & External auditor experience.
- Working knowledge of ISO17025, ISO9001 & ISO13485 a distinct advantage.
- Proven ability to train staff on complex and technical subject matter.
Please contact Emer Moore to discuss in confidence