Ref No: AM17300
Co. Dublin, Ireland
NPI Quality Engineering Manager - South Dublin.
We are recruiting a NPI Quality Manager who will play a pivotal role in site process improvement activities, and will be the central point of contact for key customers. Duties will include management and approval of process validation studies, project management, application of SPC to current production processes and liaison with key partners.
IN THIS ROLE YOU WILL BE RESPONSIBLE FOR:
Providing support for the ISO13485 Quality System.
Ensuring alignment to all corporate, external and appropriate regulatory requirements.
Supporting production personnel in relevant continuous improvement activities (Six Sigma).
Day to day Leadership/Management of the New Product Quality Engineering Team. Lead and develop the team through involvement, delegation, and regular reviews of performance.
Set up & management of key quality system elements relating to direct production support, such as the non-conformance system, incident reporting system, and customer complaint analysis.
Liaise with the R&D Department to ensure compliance to Product Specifications
Ensure all CAPA's under your responsibility are completed in compliance with all regulatory and procedural commitments
Develop and implement validation strategy for IQ, OQ and PQ requirements.
Ensure verification activities undergo test method validation to ensure consistent operation of the test equipment and results for the intended use
Interested applicants should have:
A third-level qualification in an Engineering or Science field (a post-graduate qualification in a related area would be advantageous).
A minimum of 5 years' work experience in an ISO 9001/2000 or ISO 13485 environment, coupled with a background in Medical Devices or the Pharmaceutical industry.
Experience in the preparation of technical documentation.
At least 3 years' supervisory experience.
Knowledge of Statistical Process Control and Six Sigma methodologies (Greenbelt Certification would be advantageous).
Experience in CAPA system management.