Robert Cassady

About Robert Cassady

I led enterprise-level quality system transformation across global distribution and manufacturing environments. Recognized for advancing QMS maturity, regulatory compliance, and operational efficiency, I’ve delivered real impact, achieved zero FDA 483s since 2013, secured multimillion-dollar cost savings, and standardized global processes.At Medtronic, I served as Management Representative for U.S. Distribution operations, overseeing the QMS across multiple sites and 3PL partners. I led the global development of visual packaging and shipment preparation standards, supported the award-winning Cosmetic Fix process, and championed $20M+ in scrap reduction savings.Earlier, I led a quality culture transformation across Medtronic’s Americas distribution network and supported post-merger integration with Covidien. I developed a KPI dashboard, aligned ERP systems, coached site leaders, and ensured audit readiness, achieving zero inspection findings.At Wright Medical, I was Management Representative and CAPA Board Chair, resolving 12 major ANVISA findings and preparing the site for an MDSAP Stage 2 assessment. I’ve also led QMS harmonization, supplier controls implementation, and paperless repackaging initiatives, resulting in annual savings exceeding $6M+ and improvements to global quality operations.I bring a systems-focused, compliance-driven mindset and a commitment to continuous improvement. Whether leading audits, coaching cross-functional teams, or optimizing global QMS frameworks, I aim to deliver sustainable results that protect customers and advance business goals.Key Strengths:Quality System Management (QMS)| Internal & External Audit Readiness | FDA / GMP / ISO 13485 | CAPA Ownership | Distribution & 3PL Oversight | Process Standardization | KPI Dashboarding | ERP & PLM Alignment | Cost Reduction | Lean / OPEX Tools (MOS, COS)| Regulatory Interface | Team Leadership & CoachingSelect Achievements- Achieved $20M+ in scrap savings through global standardization and visual packaging standards- Maintained zero FDA 483s while leading major distribution and 3PL transitions- Successfully resolved 12 major ANVISA audit findings at Wright Medical- Saved $6M+ annually through paperless repackaging and Lean system redesign- Led QMS harmonization and ERP alignment during post-merger integrations.I’m currently pursuing senior-level quality leadership roles where I can elevate operational excellence, compliance strategy, and QMS maturity across dynamic global organizations.Let’s connect.

Experience

1. Quality Systems Director

   Medtronic

   Jul 2019 — Present

Education

• The University of Memphis

  BSME