Role: Quality Manager - NPI
Based in Dun Laoghaire – on site role
Benefits: Competitive salary, Healthcare, bonus or share options and Pension contribution, excellent opportunity to expand your career in exciting Medical Device company growing from strength to strength.


Company:
My client have deep expertise and advanced technologies to continuously innovate their pen needles, insulin syringes and other products.


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.