NPI Quality Engineering Manager
Industry : Medical Device
The NPI Quality Engineering Manager will play a pivotal role in new product introduction 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. The NPI Quality Manager will lead the OBI quality team and has responsibility to provide required Quality inputs to the OBI program.
To provide support for ISO9000/ISO13485 Quality System.
Responsible for ensuring adherence to all BD, 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
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
Prepare and successfully execute validation activities with the site validation team to meet
NPI program timelines
Third level qualification in an Engineering or Science Discipline.
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.
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.
Proven ability of working in a cross-functional team environment.
Excellent interpersonal and communication skills and high level of computer literacy.
Location: Dun Laoghaire.
Contract Duration: 6 Months.