Role: Quality Manager - NPI
Based in Dun Laoghaire – on site role
Benefits: Competitive salary, Healthcare, bonus or share options and Pension contribution


Company:
My client have leveraged deep expertise and advanced technologies to continuously innovate their pen needles, insulin syringes and other products. They offer an excellent opportunity for anyone looking to grow their career in the Medical Device industry.



Job Purpose:

• To provide support for ISO9000/ISO13485 Quality System.
• Responsible for ensuring adherence to all external and appropriate regulatory requirements.
• Become a key member of the Dun Laoghaire Quality Leadership Team.
• Support OBI program personnel in relevant continuous improvement activities (Six Sigma).
• Day to day Leadership/Management of NPI Quality Engineering Team. Manage and develop the team through involvement, delegation, and regular reviews of performance as established in IIGs (goals).
• Management of Key quality systems elements relating to direct production support such as the non- conformance system, incident reporting system and customer complaint analysis.
• Management of Quality control group and their activities.
• Driving key changes and improvements in the Quality assurance and control systems.
• Liaise with key external customers.
• Ensure all CAPAs under your responsibility are completed in compliance with all regulatory and procedural commitments.
• Supporting key changes and improvements in manufacturing relating to product quality.
• GMP oversight and compliance of Production and Quality Engineering activities.
• Supporting key changes and improvements in manufacturing relating to product quality

• 5+ years work experience in an ISO 9001/2000 or ISO 13485 environment, coupled with a background in Medical Devices/Pharmaceutical Industry.
• Experience in the preparation of Technical Documentation.
• 3+ years supervisory experience.
• Knowledge of Statistical Process Control and Six Sigma methodologies (Greenbelt Certification would be advantageous).
• Experience in CAPA system management.
• A working knowledge of FDA requirements and managing FDA audits.
• Experience in process validation, Sterilization and working in a clean room environment would be advantageous.