Quality Manager - NPI

Role: Quality Manager - NPI

Location: Dun Laoghaire - on site role

Benefits

Competitive salary, Healthcare, bonus or share options and Pension contribution, excellent opportunity to expand your career in an exciting Medical Device company growing from strength to strength.

Company

My client has 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.

Responsibilities

• 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 the 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 the 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.
• Support key changes and improvements in manufacturing relating to product quality.
• GMP oversight and compliance of Production and Quality Engineering activities.

Qualifications

• 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.

If you are interested in applying, forward your up-to-date CV to the link provided or for more info call me at or email