Our client, a medical device company in Galway is currently looking to recruit an Associate Quality Engineer for their site.
- Reporting to Senior Engineer or Engineering Supervisor within the Sterility Assurance department you will complete sterility assurance / sterilization validation activities for new products and changes to existing validated products.
- You will support cross functional teams to design protocols to ensure that new products/ product changes are adequately evaluated/tested to guarantee compliance to all regulatory standards.
- You will liaise with extended product development project teams, developing strong partnering relationships with these groups, at both the manufacturing and design sites.
- You will be responsible for supporting your projects in internal and external audits and submission preparation and addressing any questions regarding these submissions.
- You will be responsible for keeping abreast of industry best practice with respect to validations and laboratory test methods/techniques.
- You will support root cause investigations and drive continuous improvement in day-to-day activity.
- You will liaise with departments, both internally and externally to build strong collaborative partnerships.
- We are looking for a qualified person to Minimum of a Bachelor’s degree (Level 8 NFQ) in a relevant technical discipline (e.g. Engineering, Science)
- Minimum of 2 years relevant experience.
- You are a dynamic team player and can work effectively and proactively on cross-functional teams.
- You are experienced with validation of a minimum of one sterilization technology. Experience with a number of different sterilization technologies, EO, irradiation, Steam, Chemical, Dry heat etc. and the associated standards is desirable.
- You take accountability and strive to deliver results and maintain the highest standards.
- Problem solving skills and ability to understand complex data / scenarios are essential.
- You are a good communicator and fluent in English, both in writing and speaking.
For further information on this Associate Quality Engineer role in Galway please contact Orla Crowley on 0860449473 / email@example.com
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