Description
Quality Validation Support EngineerMy client is urgently seeking an experienced Quality Validation Support engineer as part of their expansion. They are a market leader in the development and manufacture of complex drug delivery and diagnostics devices. This is a varied and challenging role in a highly successful organisation.
Responsibilities of Position:
Provide technical support during the NPI process in ensuring that from a Healthcare/Medical device perspective that all FDA, QSR, & MDD standards are achieved and maintained in respect to device classifications.
Fully competent in the generation and application of quality engineering tools and techniques with key emphasis on validation protocols (DQ, IQ,OQ, & PQ), cGMP, PFMEA's
Individual with an experienced background in, moulding, automation, equipment/software validation preferable.
Individual with an experienced background in manufacturing within controlled environments.
Individual shall support the external & internal Quality Management System auditing function (auditor trained).
Individual shall have exposure & involvement in supporting the CAPA and non conformance system.
Close liaison and networking with other departments, to provide and drive quality inputs and initiatives into the overall operational activities of the company.
Background in statistical analysis preferable, i.e. Gauge R&R. CpK.
Travel may be required
Skills / Attributes:
Excellent Leadership skills, ability to motivate team members within the organisation. (Energetic & enthusiastic individual)
Excellent organisation, communication, computer, & presentation skills.
Excellent initiative, decision-making and be able to work in a core team environment.
Solution driven with emphasis on Performance and Results.
Education/Training/Experience:
Degree in Engineering / Science (Mechanical / Electronics / Chemistry) discipline.
3 to 5 years experience in Quality Engineering of Validation role.
Fully competent in Quality Management Standards.
An excellent salary of €45,000 - €50,000 is on offer. Interviews will be immediate as this is a very urgent requirement. Please contact me Adele Moran on for more information and click apply now for immediate consideration.
To find out more about Real please visit www.realstaffing.com