Job Title
Quality Engineering Manager - NPI: South Dublin
About the Role
We are seeking an experienced Quality Engineering Manager to lead critical projects for new product introduction at our plant in South Dublin. This is a key leadership role that involves managing validation studies, working closely with internal and external stakeholders, and providing guidance to the Quality Engineering team.
Main Responsibilities:
* Sustainability of Quality Management Systems: Ensure alignment with international standards such as ISO 9000 and ISO 13485, crucial in the medical devices/pharmaceutical industry.
* Regulatory Compliance: Ensure all activities meet company and external regulatory requirements.
* Leadership: As a member of the Quality Leadership Team, 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, including non-conformance, incident reporting, and customer complaint analysis.
* Customer Interaction: Liaise with key external customers to ensure quality standards meet customer expectations.
* 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 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.