Exciting new opportunity to work with a leading medical device company based in Donegal.
CREGG Recruitment is seeking a Quality Engineer for our medical device client based in Co. Donegal.
Responsible for Quality Engineering related activities focused on timely system maintenance and development to ensure the effective introduction of new products into the company, as well as updates to the existing product family matrix.
This position works closely with the NPI Team and will support the future development and maintenance of the QMS.
- Participate in cross functional teams to establish New Product Introductions (NPI) project strategies and objectives, and critique same in the identification and mitigation of Risk.
- Monitor the progress of NPI projects ensuring that continuous drive / focus is effective.
- Work within a cross functional team (CFT) involved in NPI and associated Change Control (CC) to provide the necessary critique and support necessary to identify and set about the mitigation of same prior to handover to operations. Support all steps of the CC & NPI processes, mainly:
- Initial Quality Assessment
- Vendor Selection, Assessment & Qualification
- Validation Requirements
- Provide input from a quality perspective to product & process risk assessments, pFMEA, taking on the responsibility for executing work to the Risk Assessment Procedure.
- Pilot Production & Product Approval
- Ongoing Quality & Regulatory requirements
- Support the Quality Engineering elements of these processes, updating and improving the Quality System as required.
- Liaise directly with vendors & customers, regarding interpretation of specifications, building strong relationships. As required, coordinate & discuss essential project points with customers in line with their requirements.
- Provide support to Quality System elements: Validation, Metrology, Document Control.
- Support the QMS as per ISO 13485, with particular focus on CAPA system, Continuous Improvement activities, internal audit system. Support the wider Quality Engineering Team as required.
- Liaise with other internal departments as required as part of day-to-day activities.
- Represent Quality at internal audits, external audits, and on CFTs for risk assessment, CAPA, Continuous Improvement, new product introductions
- Third level qualification to Degree level in Quality, Engineering, Science or related discipline.
- Minimum 3 years in a similar role in the medical device industry preferred.
- Knowledge of ISO 13485, MDD, FDA requirements
- Have the ability to work within the QMS using own initiative, with a proven track record in a similar role
- Strong project management capabilities.
- Excellent attention to detail and accuracy
- Excellent attention to detail in oral & written communication, with a proven technical protocol & report writing background
To apply for this role please submit CV's through the link provided or call Caroline Fanneran on
086 790 2885 for a confidential discussion.
**Candidates eligible to work in Ireland are only being considered at this time**