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Quality Engineering Manager - NPI: South Dublin, Dublin
Client:
ICDS Recruitment
Location:
Dublin, Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
504b6b5db1f7
Job Views:
59
Posted:
22.01.2025
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:
1. 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.
2. Regulatory Compliance: Ensuring that all activities meet company and external regulatory requirements.
3. Leadership Role: Being a key member of the Quality Leadership Team, leading the Quality Engineering Team through daily management, performance reviews, and delegation.
4. Continuous Improvement: Supporting programs like Six Sigma to enhance processes and product quality.
5. Quality System Management: Overseeing systems related to production support, such as non-conformance, incident reporting, and customer complaint analysis.
6. Customer Interaction: Liaising with key external customers to ensure that quality standards meet customer expectations.
7. CAPA Management: Ensuring Corrective and Preventive Actions (CAPAs) are completed in compliance with regulatory standards.
8. GMP Oversight: Ensuring Good Manufacturing Practice (GMP) compliance in Production and Quality Engineering activities.
9. Documentation: Preparing and maintaining documentation to meet regulatory requirements.
Education & Experience Requirements
1. Industry experience: At least 5 years in an ISO environment, preferably in the medical devices or pharmaceutical industry.
2. Supervisory Experience: A minimum of 3 years in a supervisory role, indicating the need for leadership skills.
3. Technical Knowledge: Understanding of Statistical Process Control (SPC) and Six Sigma methodologies, with Greenbelt Certification being advantageous. Advanced Technical writing skills are required.
4. Regulatory Knowledge: Experience with FDA requirements and audits.
5. Process Expertise: Experience in process validation, sterilization, and cleanroom environments is a plus.
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