A Major Global Medical Devices Company in Galway, Ireland wish to recruit a suitably qualified person for the following post:
SENIOR QUALITY ENGINEER - STERILE
Our Sterile Release Department is service-oriented, supporting multiple Company businesses. Sterile Release facilitates the post sterilisation release of drug combination and medical device products to the market.
As a Senior Quality Engineer, your role and responsibilities will include;
* Directly involved in system development associated with new product uploads/technology transfers and activities outside of routine product releases
* Drive continuous improvement in day to day activities on your own initiative
* Contribute and lead complex investigations associated with sterilisation non-conformances and deviations, using robust root cause analysis tools and in the identification of appropriate corrective action measures
* Develop system to ensure early visibility of change initiatives and new product introductions from across the site, that impact Sterile Release processes
* Establish performance metrics/KPI's and associated visual management systems for Sterile Release area.
* Provide technical input/impact assessment from Sterile Release processing perspective for initiatives such as rework campaigns, product conversions, system updates etc
* Lead and support CAPA activities within Sterile Release
* Training relevant personnel on applicable Sterile Release processes
* Coach and develop others to achieve maximum performance
* Support audits and interacting directly with external auditors
We are looking for a qualified person to Third Level 8 Degree in Science, Engineering or related discipline and desirably with further postgraduate study in Project Management and/or Quality related discipline and a working knowledge of Lean Sigma principles experience.
You are a dynamic team player and leader and can work effectively and proactively on cross-functional teams.
You are experienced with the ability to be self-directed and to effectively interface with various levels and functions within the organization. Ability to recognize, anticipate and innovatively create solutions to issues and problems in a timely manner is desirable.
Having broad technical expertise and knowledge of interrelated quality function disciplines and a high level of aptitude in QE/QA principles and methodologies is advantageous.
A good working knowledge of process validation requirements would be beneficial.
You are a good communicator and fluent in English, both in writing and speaking.
Leadership Expectations provide the framework for what we expect from all employees at the Company - outlining the actions and behaviors we must develop and demonstrate in pursuit of our Mission and global growth goals.
Excellent Salary/Benefits package on offer
For immediate interview, please email your CV to
For informal enquiries, please telephone Christy on 087 9473404 or 00353 87 9473404 (if outside Ireland)