Prem Gosain

About Prem Gosain

Enterprise Quality Leader with 20+ years of experience driving quality transformation, regulatory excellence, and operational performance across global medical device, combination product (active drug–device), and medical imaging organizations, including Medtronic, Philips Healthcare, and Cretex Medical. Proven record of building scalable quality systems, strengthening global supplier networks, and enabling sustainable business growth in highly regulated environments, manufacturing Class I, II, and devices. Recognized for aligning quality strategy with business performance, building high-performing global teams, and guiding organizations through regulatory scrutiny, audit readiness, operational scale-up, and transformation initiatives

Experience

1. Senior Director of Quality

   Cretex Medical

   Nov 2025 — Present · Minneapolis, MN, US

   Provide strategic leadership for enterprise Quality, setting vision, priorities, and metrics to enable business growth, customer confidence, and overall achievement of organizational goals• Serve as a member of the business leadership team and Management Representative, ensuring compliance with U.S. & global medical device regulations across development, manufacturing, supplier quality, & commercialization.• Build and advance a high-performing Quality organization, strengthening talent, accountability, and a culture of continuous improvement.• Develop and deploy effective risk-based Quality Systems and audit readiness to ensure sustainable process excellence and best-in-class practices.• Drive continuous improvement across the organization through effective Quality Systems, Lean methodologies, and best-in-class practices.

Education

• Medtronic

  Lean Six Sigma Green Belt

• The Maharaja Sayajirao University of Baroda

  Bachelor of Mechanical Engineering

• University of St. Thomas

  Master of Business Administration (MBA)