Quality Engineer II

Galway, IrelandOn site10 days ago

Job description

Purpose: As an experienced quality professional, ## What you'll do support the successful delivery of projects by ensuring quality and compliance ## What you'll bring are effectively integrated throughout the project lifecycle. You will demonstrate a commitment to the Quality Policy, patient safety and product quality through the application of sound quality principles, risk-based decision-making and cross-functional collaboration. You will maintain and promote an effective quality management system, ensuring compliance with all applicable regulatory and company requirements while driving project success and upholding high standards of patient safety, product quality and regulatory compliance Key Responsibilities: - Take a preventive approach to quality assurance by proactively identifying potential issues. - Provide direction and support to colleagues based on subject matter expertise and Quality System knowledge. - Manage and coordinate department activities as applicable, including NCEP, CAPA, PIR escalation and complaints. - Serve as the quality lead for projects and as the site representative for Quality Catch, WSVA and other applicable initiatives. - Document nonconformances using a high standard of technical writing and a detailed understanding of containment, disposition, risk assessment and investigation. - Identify and drive corrective actions, when required, to prevent, eliminate, facilitate or mitigate the recurrence of nonconformances. - Review complaint signals and complete investigations for individual events and unfavorable trends. - Solve problems and determine appropriate actions by analyzing possible solutions and their impact on the business or technology. - Organize and present data and information to influence decision-making. - Maintain and enhance cross-functional and site team relationships. - Actively contribute to continuous improvement and innovation from a preventive quality perspective. - Collaborate effectively as a team member to achieve and demonstrate best practices aligned with department and site objectives. - Apply strong organizational and time management skills to complete work in a timely manner. - Prioritize a diverse workload to ensure the timely completion of critical tasks. - Plan and execute daily activities and long-term projects to meet established timelines. - Explain technical topics clearly to diverse stakeholders through effective communication. - Make informed decisions related to product quality, including the disposition of nonconforming product. - Apply appropriate statistical tools for sampling, capability analysis, trend analysis and control charts, and effectively interpret and present conclusions. - Participate directly in new product and technology transfers, ensuring compliance with applicable internal and regulatory requirements. - Support change control for work instructions, protocols, reports and technical documents as a change owner or quality approver. - Apply knowledge of QSR and ### Iso/Mdd standards, promote awareness of industry best practices and make appropriate daily quality decisions, escalating critical quality decisions to the Quality Manager or Quality Director as appropriate. - Apply knowledge of risk management principles to support effective, risk-based decision-making. Education & Experience: - Level 8 Hons Bachelor Degree (or higher) in Engineering or related field - Minimum of 5 years' relevant experience, ideally within the medical device industry or another highly regulated environment. …