Overview
Requisition ID:
-0
JOB TITLE:
NPI Quality Engineer
DEPARTMENT:
Quality Department
REPORTING TO:
Quality Engineering Manager
DIRECT REPORTS:
N/A
Responsibilities
Quality: Assure ongoing compliance with quality and industry regulatory requirements.
Health & Safety: 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, analyzing 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).
Effective step by step release and Quality checks of all New Product introduction phases covering risks in supply chain, component and material selection and fit for purpose suitability.
Implement a detailed step by step Standard operating procedure that effectively covers all aspects of effective New Product introduction.
Make NPI process more objective based with emphasis on minimum requirements for base line NPI process effectiveness utilizing SOP mentality and evidence based checks for all steps required in NPI process.
Introduce objective Transfer to Manufacturing approval process ensuring each NPI is released to normal production with all aspects of the process defined and working to the required set out in Process Qualification phase.
Measurements
Yields at Key Process Steps for all NPI activity
Customer Return % and Cost (RMA)
Scrap %
Outgoing Inspection DPM & Customer Incoming Quality Levels
NPI success rate and post shipment trending
NPI reports covering effective and detailed action list identifying area for improvement / owners of actions and definitive follow up and closure of open actions prior to any follow on manufacturing.
Personnel Specifications
Essential
Degree / Diploma in Science or Engineering, or a lesser qualification with 5-10 years sufficient job related experience in a PCBA printed Circuit board assembly environment.
Must have in depth knowledge of Surface Mount Technology assembly lines 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.
Sound understanding and utilization of Problem Solving Techniques
Must have indepth understanding of IPC-A-610 manufacturing of printed circuit board assembly standard and clearly understand requirements of the standard.
Proficient in the use of Microsoft Word, Power-point and Excel.
Good Communications and strong influencing skills as well as ability to define New Product Introduction Quality controls from Purchasing controls to final shipment controls must have in-depth knowledge of entire process required to introduce new products.
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.
Desirable
Experience in working within a Class 3 Medical Device Manufacturing Environment.
Six sigma Green or Black Belt Certified
Knowledge of PCB Printed circuit board design requirements versus IPC standard.
Experience of working with Fuji Surface Mount equipment such as solder paste inspection, NXT placement machines, Reflow oven criticality, Automated Optical inspection and general Statistical process control as well as familiarity with product testing such as In Circuit test, Functional test platforms.
Apply Back to results
#J-*****-Ljbffr