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Job Description
Lead Quality Engineering Manager for NPI in South Dublin, responsible for leading critical projects for new product introduction at the plant, ensuring quality management systems align with international standards, and working closely with internal and external stakeholders.
This role involves providing leadership to the Quality Engineering team, managing validation studies, and ensuring regulatory compliance. The successful candidate will have a strong understanding of Statistical Process Control (SPC) and Six Sigma methodologies, with Greenbelt Certification being advantageous.
Key Responsibilities:
- Support ISO9000/ISO13485 Quality Systems
- Regulatory Compliance
- Leadership Role: Lead the Quality Engineering Team through daily management, performance reviews, and delegation
- Continuous Improvement: Support programs like Six Sigma to enhance processes and product quality
- Quality System Management: Oversee systems related to production support, such as non-conformance, incident reporting, and customer complaint analysis
- CAPA Management: Ensure Corrective and Preventive Actions (CAPAs) are completed in compliance with regulatory standards
- GMP Oversight: Ensure Good Manufacturing Practice (GMP) compliance in Production and Quality Engineering activities
- Documentation: Prepare and maintain documentation to meet regulatory requirements
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/managerial role
- Technical Knowledge: Understanding of 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