A Quality Engineer is required by CareerWise Recruitment for our Cork based med device client. This is a 12 month initial contract role. Please contact Diarmuid Buckley for full details.
* Team member representing the Quality function supporting projects in Materials Development with a focus on metals forming processes. * Support Quality and Validation activities for product transfers and new product introductions. * Responsible for ensuring conformance with current equipment, process, and systems validation regulations. * Assess effectiveness of measurement tools, destructive tests, non-destructive tests (measurement system analysis). * Determine process inputs and factors for variation where process capability is required. * Responsible for conducting (where appropriate) Installation, Operating and Performance Qualification (IQ,OQ, PQ). * Develop pFMEA documentation to support processes as part of Validation process * Conduct investigation, bounding, documentation, review and approval of non-conformances and CAPAs related to Materials projects. Escalation of quality issues as appropriate. * Support root cause analysis activities related to material processes. * Communicate effectively with global functions and internal team on actions and deliverables.
* BSc in Engineering or Science with ?2 years' experience in a medium to high volume manufacturing environment * 1 year in a similar capacity in a regulated industry (i.e. FDA/ISO) * Ideally -experience working in both an FDA and European regulatory environment iwith an in depth knowledge of 21 CFR 820, CFR 11 and European regulations associated with the medical device industry. * Understanding of GMP/ISO and validation regulations.
Please call Diarmuid Buckley today for further information on 021- 4355432 or email: firstname.lastname@example.org CareerWise Recruitment (In Search of Excellence) CareerWise Recruitment specialises in the multinational sector in Ireland which predominantly encompasses the Medical Device, Sciences/Pharma and ICT industries. We also work into the Indigenous Engineering and Food Processing/Agri sectors.
Established in 1999, CareerWise Recruitment is recognised by many of the major indigenous and multinationals companies to be one of Ireland's leading specialist Technical and Executive Recruitment firms.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway and Dublin.
Supporting Business Demands & Growth since 1999
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