Telephone: 086 8395533
Quality Engineer - Sterilization Validation/Biocompatibility
Our client, a medical device company in Galway are currently looking to recruit a Quality Engineer for their site.
- At our Sterilization Validation/ Microbiology/ Biocompatibility Services Department we focus on product quality excellence and providing exemplary service to the business units we support.
- Quality Engineers are directly involved in building the organization in support of Sterility and Biocompatibility Assurance for NPD and Site Transfers.
- You will lead sterilization validation and / or biocompatibility assurance for new products and change control.
- 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) and desirably with 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 Sterilisation Validation or Biocompatibility.
- Experience with a number of different sterilization technologies, particularly chemical is desirable.
- Leadership Expectations provide the framework for what we expect from all employees at Medtronic.
- Thinks critically and Makes Sound Decisions, Collaborates and Creates Alignment, Focuses on Patient and Customer and Sets High Standards for delivery are a must for this role.
- 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 outlining the actions and behaviours we must develop and demonstrate in pursuit of our Mission and global growth goals.
For further information on this Quality Engineer role in Galway please contact Bimi Felix on 086 8395533 / firstname.lastname@example.org
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