Quality Manager (NPI) - Medical Device

Job Description

The purpose of this role is to lead the quality activities and the project quality team related to an innovative NPI product being rolled out at site.

This individual is a key cog in the successful implementation of a new NPI product to the Dublin facility. This is an onsite role and will support operations with the introduction of this new technology from a Quality and compliance standpoint. This role will also be the central customer contact point and will lead a team of 7-8 individuals. The project is projected to last close to 3 years.

A bit more about the role:

• To provide support for ISO9000/ISO13485 Quality System.
• Responsible for ensuring adherence to all business, external and appropriate regulatory requirements.
• Become a key member of the Quality Leadership Team.
• Day to day Leadership/Management of NPI Quality Engineering Team. Manage and develop the team through involvement, delegation, and regular reviews of performance.
• 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.
• Prepare and Maintain documentation in compliance with appropriate regulatory requirements.
• 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

Education & Experience

• 5+ years work experience in an ISO 9001 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, Sterilisation and working in a clean room environment would be advantageous.
• Prior experience in project management or the implementation of site projects is highly preferred.

If you would like to find out more about this role please click the 'Apply Now' button below or reach out to Kellie on 021 2300 300.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

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