Brian Schwarz

Background

About Brian Schwarz

Experienced, proven, and visionary Quality Senior Executive with a track record of creating teams and processes from scratch. For example, each of my last four roles was brand new, allowing me to understand the need, define success, build, and run successful processes and teams.• Proven excellence in Global Quality Systems, with full-spectrum quality experience including Design (product and process), Supplier, Operations Quality, Commercial Quality, QMS, and Post Market in both the corporate and factory contexts. This includes leadership of transformative global One QMS project (consolidating from 13 Quality Systems worldwide to one). • Expert in Product / Operations Quality including Quality Engineering, Operations Quality, and Continuous Improvement as Six Sigma Master Black Belt certified (and DFSS trained). Helped build Product Quality toolkits which became the corporate standard (process development and validation, supplier management, in-process QA). Experience across multiple product types, including high-volume and low-volume disposables, durable capital equipment, software (embedded and standalone) across Class I, II, and devices, pharmaceuticals, and combination products.• Leadership experience interfacing with Global Regulatory Compliance agencies (US FDA, MHRA, ANSM) having been involved with 15+ FDA inspections of all types around the world. Served as both factory and global Management Representative for US FDA and PRRC for EU MDR.• Demonstrated business acumen and global executive leadership, responsible for team of 250+(direct and indirect) across 13 countries and five factories with annual budget of $11MM USD.