Job Description
Quality Engineering Manager - NPI This role is responsible forleading critical projects for new product introduction and sustaining at our clients site in South Dublin. This involves providing leadership to the Quality Engineering team (5-7 associates), managing validation studies, and working closely with various internal and external stakeholders. Key Responsibilities Support ISO9000/ISO13485 Quality Systems: Ensuring the company's quality management system aligns with these international standards, which are crucial in the medical devices industry. Regulatory Compliance: Ensuring that all activities meet internal and external regulatory requirements. Leadership Role: Being a key member of the Quality Leadership Team, leading the Quality Engineering Team through daily management, performance reviews, and delegation. This candidate will need to have strong stakeholder management experience. Continuous Improvement: Supporting programs like Six Sigma to enhance processes and product quality. Quality System Management: Overseeing systems related to production support, such as non-conformance, incident reporting, and customer complaint analysis. Customer Interaction: Liaising with key external customers, to ensure that quality standards meet customer expectations. CAPA Management: Ensuring Corrective and Preventive Actions (CAPAs) are completed in compliance with regulatory standards. GMP Oversight: Ensuring Good Manufacturing Practice (GMP) compliance in Production and Quality Engineering activities. Documentation: Preparing and maintaining documentation to meet regulatory requirements. Education & Experience Requirements Industry Experience: At least 5 years in an ISO environment, preferably in the medical devices industry. Supervisory Experience: A minimum of 3 years in a supervisory role, indicating the need for leadership skills. Technical Knowledge: Understanding of Statistical Process Control (SPC) and Six Sigma methodologies, with Greenbelt Certification being advantageous. Advanced Technical writing skills are required. Regulatory Knowledge: Experience with FDA requirements and audits Process Expertise: Experience in process validation, sterilization, and cleanroom environments is a plus. Any applicant must be resident in Ireland, or willing to relocate to Ireland. This person needs to have established people management experience, with proven examples. The ideal candidate must be a strong communicator with fluent English and stakeholder management experience. This is an onsite role. Skills: Quality NPI systems people management medical devices.