Joshua N. Arnold
SUMMARY OF QUALIFICATIONS
• ASQ Certified Quality Engineer and Certified Six Sigma Black Belt, ISO 13485 BSI Certified Lead Auditor, experienced working in ISO 13485 and 21 CFR 820 regulated industries
• Knowledgeable in DMAIC and root cause analysis approaches
• Excellent technical writing ability and verbal communication, strong technical background, highly motivated, adaptable and able to drive for results
EXPERIENCE
Quality Engineer, New Programs
Norwood Medical, Dayton, OH 2013 – Present
• Provide technical quality and design control expertise in development of processes for production of new/modified medical device components
• Develop inspection criteria and work instructions based on customer defined CTQs and internal in-process manufacturing requirements
• Coordinate and execute qualification activities encompassing New Product Life Cycle: PQ, Gage R&R, process capability, SPC, FAIs
• Prepare reports, analyze data and present recommendations to customers and management
• Develop process capability while managing process sigma
• Create project PFMEAs to determine areas requiring risk reduction, process flow diagrams to reduce sources of process waste, control charts to ensure sustainable processes
• Authored new manufacturing inspection procedures for use by machine operators and modified existing plans following the change management process
Supplier Quality Engineer
Abbott Vascular, Temecula and Menlo Park, CA 2011 – 2013
• Drove improvement and corrective action in the quality of components sourced from outside suppliers, developed acceptance criteria and inspection procedures for incoming materials
• Provided technical support in the selection of suppliers by assessing technical, quality, reliability and manufacturing capabilities, specifically through the use of process capability and Gage R&R analysis
• Analyzed incoming material defects, dispositioned and drove corrective actions to completion, monitored manufacturing yield issues and field failures based on supplier performance, communicated issues to suppliers, identified root cause and developed action plans to reduce repeat occurrences
• Authored test method validations for software programs of measurement equipment used in incoming quality assurance, analyzed results using Gage R&R methods
• Led cross-functional team of internal and supplier project resources to reduce corrugated packaging non-conformances and line down time by clarifying critical inspection points
• Assisted in roll-out of OneException system for electronic exception management, helped prepare international regulatory submissions by compiling supplier material certifications
Production Chemist II 2010 – 2011
Alere San Diego Inc., San Diego, CA
• Synthesized organic compounds utilizing complex laboratory equipment, calculated product yield and offered process improvement recommendations
• Tracked and monitored sources of process variation, nonconforming materials and defects, completed assigned tasks to close out NCMRs and ensured timely completion
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