Validation Engineer

As a Validation Engineer at our Newport site, you will: Validation Leadership

• Develop and implement the site validation program for products, processes, equipment, software, and test methods, ensuring compliance with ISO 13485 and IVDR standards.
• Lead test method validation initiatives to enhance inspection accuracy and reliability.
Problem-Solving & Quality Improvement
• Perform root cause analysis and implement corrective actions for process-related issues, driving continuous improvement across operations.
• Champion quality system enhancements through methodologies like Six Sigma, 5S, and Lean Manufacturing, fostering a culture of operational excellence.
• Lead technical quality training programs to upskill teams in areas like risk management (ISO 14971), validation, statistical techniques, and RCA methodologies.
• Facilitate timely and effective resolution of customer complaints, supplier deficiencies, and quality concerns, ensuring customer satisfaction.
Multi-functional Collaboration
• Partner with Engineering and Operations to ensure seamless transfer of new products to production, meeting customer and regulatory expectations.
• Work closely with suppliers and customers to address complaints, investigate failures, and ensure robust closure
Compliance & Auditing
• Conduct internal and external audits, addressing findings with thorough reports and actionable corrective/preventive measures.
• Drive compliance and enhance quality systems in alignment with regulatory and customer requirements.
  
  Bachelor's degree in Science or Engineering
• Excellent problem solving and analytical skills and developed understanding of risk management
• Excellent oral and written communication skills
• Excellent digital literacy
• Ability to work independently and proactively
• Demonstrated leadership ability
• Experience in Medical Devices (PFMEA, Control Plan, CAPA)
• Solid understanding of ISO 9001 and ISO 1348
• Experience working in a GMP environment such as Medical Device industry or plastic consumables
• Statistical Analysis Tools such as Minitab or JMP, SAP, TrackWise, Microsoft Excel, Visio, Power Point, and MS Project