Experience

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  Medtronic

  Jan 1998 - Jan 2023

  Managed large supplier changes, including facility moves, manufacturing technology transfers, material and sourcing changes, and component materials changes. Led the completion of supplier audits, including several urgent desktop ISO audits during the COVID-19 pandemic, quality performance reviews (QPRs), control plans, and various supplier manufacturing changes. Worked with design, sourcing and commodity, reliability, materials, and regulatory departments to implement medical device changes requiring FDA approval.Qualification / re-qualification of supplier changes (Supplier moves, new supplier, new materials), includes rigorous internal review to ensure medical grade quality was maintained (material, bio, micro bio testing, etc.). Show less Managed commodity-related quality control procedures and corrected functional issues stemming from problematic components. Identified quality control discrepancies that disrupted production and worked with senior management to resolve supplier quality issues. Transferred component inspection to the suppliers.Developed incoming inspection and quality procedures, completed quality audits (ISO 13485) with key suppliers, and qualified new components to medical device standards. Actively worked cross-functional (design, regulatory, purchasing, biomaterials, etc.) leading most of these component introductions to ensure component completion and approval. Performed ongoing MRB related activity with incoming product. Show less Managed supplier quality through internal quality inspection, including the movement of paper incoming inspection procedures (IPs) into Medtronic’s electronic material analysis and qualification system (MAQS) IP management system. Activity included Software validation, as well as updates to 300+ IP's being transferred to the electronic incoming inspection system. Resolved component issues (SCAPAs) through active and open communication with the supplier’s quality and management teams, driving issue resolution/ problem solving through root cause analysis using 8D, Fishbone, 5 whys and other DMAIC process tools. Show less

  • Principal Supplier Quality Engineer

    Jan 2017 - Jan 2023

  • Principal Supply Chain Development Engineer & Project Manager

    Jan 2015 - Jan 2017

  • Principal Supplier Quality Engineer

    Jan 2012 - Jan 2015

  • Senior Component / Supplier Quality Engineer

    Jan 2006 - Jan 2012

  • Senior Supplier Quality Engineer

    Jan 1998 - Jan 2006