Npi Quality Engineer
Careerwise Recruitment
Cork
A NPI Quality Engineer is required by CareerWise Recruitment for our Cork based advanced medical device client. This is an initial 12 month contract role. Please contact Diarmuid Buckley for more information. THE ROLE: * Management of all Quality requirements and approvals required to achieve first time approval of NPI introduction based on Customer requirements. * Generation of standard NPI Quality template to drive robust approach to all NPI activity. * Overall responsibility for generating comprehensive Quality plan and associated DHR appendix covering all Customer requirements as per any applicable Quality agreement. * Overall responsibility for generating comprehensive team compiled Control plan and FMEA including process challenges and validation requirements prior to IQ/OQ/PQ phase. * Data collection, analysing and reporting of all NPI activity including standard template to document all NPI issues and concerns. * Pareto and trend analysis of all NPI activity. * Initiate and drive Continuous Improvement programs based on NPI / Engineering prototype builds from Surface Mount assembly to any associated Post SMT Surface Mount Assembly requirements. * NPI Approval including First Article Inspections and Reporting. * QSR Validation protocols and report (IQ, OQ & PQ. REQUIREMENTS: * Degree / Diploma in Science or Engineering, or a lesser qualification with 5-10 years experience in a PCBA printed Circuit board assembly environment. * Knowledge of Surface Mount Technology assembly process and associated Post SMT process control such as In Circuit Test, Flying Probe, Functional Test, Quality sampling and Batch release control. * At least 2-3 years Quality Assurance / Regulatory affairs experience, in a similar Quality Engineering role in the electronics manufacturing industry. * Must have in-depth understanding of IPC-A-610 manufacturing of printed circuit board assembly standard and clearly understand requirements of the standard. * Ability to respond to common inquiries or complaints from internal customers and regulatory agencies. * Ability to write standard operating procedures, training documents, and regulatory responses. Please call Diarmuid Buckley today for further information on 021- 4355432 or email: dbuckley@careerwise.ie. 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. CareerWise Recruitment. In Search of Excellence. We provide recruitment services in the areas of Engineering, Supply Chain, Sciences, IT and Accounting & Finance. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway and Dublin. Supporting Business Demands & Growth since 1999. This job originally appeared on RecruitIreland.com.
2166 days ago