NPI Quality Manager

Our client a multinational medical device company are currently seeking a NPI Quality Engineer to join their team. Reporting to Senior Quality Engineering Manager the NPI Quality Manager will play a pivotal role in site process improvement activities and 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.


Role/Responsibilities

• Providing support for ISO13485 Quality System.
• Ensuring alignment to all, external and appropriate regulatory requirements.
• Supporting production personnel in relevant continuous improvement activities (Six Sigma).
• Day to day Leadership/Management of New Product Quality Engineering Team. Lead and develop the team through involvement, delegation, and regular reviews of performance as established in IIGs (goals).
• Setup & Management of Key quality systems 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 CAPAs 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

• Third level qualification in an Engineering or Science Field (a postgraduate 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/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.