This role requires an in-office presence in Irvine, California. This role does not offer relocation assistance.
Responsible for processing nonconforming materials and maintaining the NCMR (VSR) system. Support NCM root cause analysis and associated CAPA. Responsible for data integrity and statistical analysis and trending of NCM processes. Support QA activities associated with Material Review Board (MRB) and processing of nonconforming materials. Coordinate and collaborate with suppliers and manufacturing on NC's and associated quality system controls.
Responsible for maintaining and effecting the Nonconforming materials (Vendor Service Requests ERP module) process and all associated activities.
Actively participate in root cause analysis and problem resolution associated with NCMs.
MRB reporting in collaboration with production, planning and engineering
Reporting of process metrics
Directly responsible for processing NCM events including evaluating impact to 'where used', investigate/correlate NCM history, containment, root cause, disposition and associated CAPA/SCAR.
Ensure NCM process is performed per procedure and all dispositions and related CAPAs/SCARs are approved per procedure prior to implementation.
Support QA/Engineering in processing statistical data and support QA in data analysis/trending related to NCMs and other monitoring/controls.
Ensure work is performed within QMS procedures, Good Documentation Practices, and customer requirements.
Defines, develops and implements quality assurance practices and procedures, validation plans and other QA assignments
Perform product inspection as needed.
Perform other duties as assigned
Must be able to read blueprints/specifications and proficient in GD&T
Inspection knowledge using industry handtools such as calipers, gages, indicators, micrometers and more advanced IMTE such as vision systems, CMM.
Competent in basic applied statistics, statistical sampling plans, and statistical process.
Ability to concurrently handle multiple project assignments.
Must be able to thrive in a fast-paced, team-oriented, new product development environment.
Understanding of standardized quality systems such as ISO13485, FDA QSR, AS9100, ISO9001.
Must have knowledge of data collection and analysis, for reporting of key performance indicators to management.
Knowledge of PC Microsoft programs with strong skills in Excel and Access
Practical knowledge of manufacturing data systems such as M2M or other similar ERP system.
Practical knowledge of Minitab.
Technical writing proficiency
Guarantee quality of products in highly regulated environment
Perform duties in compliance with applicable regulatory requirements and company SOPs.
Achieve established KPIs (Key performance indicators)
Ensure all quality aspects of this position
Maintain a safe working environment
Minimum of 0 - 2 years of experience in quality engineering, quality assurance, engineering, or manufacturing required. Experience with manufacturing of electromechanical products preferred. Must have experience in manufacturing environments and 'hands on' knowledge of inspection techniques.
ASQ Certification as a QE preferred or similar industry certification. Experience with Risk Management activities (Hazard analysis, fault tree analysis, FMEA).
BS is Scientific, Engineering or Quality Technology discipline.
Position entails some travel. Ability to work under pressure of deadlines is necessary. Physical demands include working with hands and visual demands entail close vision.
Supplier Quality Engineer 1 • Irvine, CA, United States
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