Senior QE Projects
My client are a medical device contract manufacturer, based in Galway. They provide a broad range services to design, develop and deliver finished medical devices to market. Due to my client's acquisition by a multi-billion euro technology company, their site in Galway is going from strength to strength and is home to their global HQ. Due to this growth, they need an ambitious Senior Quality Projects Engineer to join them.
As Senior Quality Projects Engineer, your responsibilities will include:
- Demonstrating commitment to the Quality Policy (product safety and quality) through the daily execution of sound quality practices.
- Leading quality related projects within the Device Manufacturing Value Stream e.g. where significant process changes are required that originates from a CAPA or a customer complaint.
- Leading cost improvement projects and NRE activities within the value stream from a quality perspective.
- Leads quality support for the transfer of new product into device manufacturing.
- Provides additional support to the operations team when a new product is introduced to the value stream where required until the product has reached steady state.
- Managing the approval of supplier change notifications.
- Supporting audits for the value stream from external regulatory agencies and customers and leads preparation activities in advance of such audits.
- Updates quality procedures, specs as required through the change plan process.
- Provides root cause analysis & problem-solving guidance and mentoring.
- Level 8 degree in Science, Engineering or related subject.
- 3-5 years of relevant supplier quality/ quality operations / quality project's experience in a GMP manufacturing environment.
- Significant project management experience
- Very experienced in new product introductions.
If this role seems like the perfect fit for you, please apply directly to this advert and I will contact you with further information.
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