Job Description
Quality Engineering Manager - NPI: South Dublin. Job Summary This 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 Requirements Industry 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. Skills: quality manager medical device npi