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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.