Senior Quality Engineer

ICDS RECRUITMENT

LIMERICK

Senior Quality Engineer - Limerick. Key Purpose: In this role you will be responsible for quality input, review, implementation, release and performance of all phases of system, product and process realisation relating to the assigned area of responsibility or Value Stream. Product development and New product introduction. Quality Management system. Manufacturing transfer, production, product release and post-production. Ensuring that the system, process and product requirements are established and kept in compliance with customer and regulatory requirements. During all phases ensure effective implementation, documentation and communication meeting internal and external Customer, Auditor and Management requirements. Key Responsibilities: • Own all quality aspects of system, product and process, development, production, release and post-production feedback. • Responsible for ensuring that risks are identified, assessed, actioned, documented and maintained for the process/product through the entire supply chain in scope of area of responsibility. • Lead multi/cross-functional project teams to drive process/system improvements and achieve milestones and results. • Represents the company in customer interactions in a professional, constructive and commercially aware manner. • Ensure that customer expectations are managed and met in all areas of business interaction. • Lead Product development, new process development or process/system improvement projects achieving the required standard in quality, cost management, health and safety assurance, productivity and sales growth. • Drive continuous process and system improvement across the board and take initiatives to make things better every day. • Own and drive the Safety/Quality/Service/Cost Metric for the Value Stream. • Excel in the technical competence required for the role: GMP’s, QSR’s, process validation, statistical techniques, process monitoring and control tools e.g. SPC. • Lead by example and demonstrate agreed behaviours. • Align goals and objective setting for the Value Stream in collaboration with management. • Execute Lean/Shingo initiatives bringing everyone else on board. • Be committed to develop, coach, motivate self and team and support development and growth of direct reports. • Leads the Value Stream based on influencing skills without having the hierarchy of all team members. • Proactively engage in new product development to ensure a smooth transition from development to production. • Build relationships with key stakeholders in the company and address their needs of communication and information. • Ensure full compliance with regulatory requirements. • Ensure Quality and EHS policies and procedures are adhered to at all times. Qualifications & Experience: • Degree in an engineering/ quality related discipline. • At least 8 years' technical experience in a similar environment. • Ideally Lead auditor. • Technical report writing skills. • Process validations/risk analysis tools e.g. FMEA's. • Understanding of Lean Principles. • Ability to drive projects to completion. • Working knowledge of EN ISO 13485:2016 principles of GMP and FDA QSR 21 CFR Part 820 required.

1598 days ago