Quality Engineer

Careerwise Recruitment

Cork

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. THE ROLE: * Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements. * Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs. * Conduct benchmarking to develop more effective methods for improving quality. * Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management. * Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc. * Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges. * Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate. * Approve IQ, OQ, PQ, TMV or Software Validation. REQUIREMENTS: * L8 Degree qualification in a relevant discipline. * 5 yrs experience in a regulated environment. * Six sigma- Certification. * Experience in performing Design of Experiments (DOE) and leading Failure Mode Effects Analysis (FMEA. * Experience of the design and qualification documentation standards to current FDA expectations. * A good understanding and working knowledge of FDA and ISO regulations. Please call Diarmuid Buckley today for further information on 021- 4355432 or email: dbuckley@careerwise.ie. 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. CareerWise Recruitment accepts that you do not wish your CV to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will be respected at all times. This job originally appeared on RecruitIreland.com.

2317 days ago