Job Title: Quality Engineering Manager - NPI: South Dublin
Ref No: DT18358
South Dublin, Republic of Ireland
Job Summary
This role leads critical projects for new product introduction at the plant. It involves providing leadership to the Quality Engineering team, managing validation studies, and collaborating with various internal and external stakeholders.
Key Responsibilities:
* Support ISO9000/ISO13485 Quality Systems: Ensure the company's quality management system aligns with these international standards crucial in the medical devices/pharmaceutical industry.
* Regulatory Compliance: Ensure all activities meet company and external regulatory requirements.
* Leadership Role: Be a key member of the Quality Leadership Team, leading 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.
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.