Social network you want to login/join with:Quality Engineering Manager - NPI: South Dublin, DublinClient:ICDS RecruitmentLocation:Dublin, IrelandJob Category:OtherEU work permit required:YesJob Reference:504b6b5db1f7Job Views:59Posted:22.01.2025Job Description:Quality Engineering Manager - NPI: South DublinJob SummaryThis role is responsible for leading critical projects for new product introduction at the plant. 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/pharmaceutical industry.Regulatory Compliance: Ensuring that all activities meet company 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.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 RequirementsIndustry experience: At least 5 years in an ISO environment, preferably in the medical devices or pharmaceutical 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.
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