Vikram Chandra

Vikram Chandra has executive global management expertise, strategic quality, and regulatory leadership experience in the medical devices industry creating a positive quality culture, improved product and regulatory processes, effective quality systems and teams, and achieving operational/organizational business outcomes. He has proven adept at creating effective cross-functional collaboration, provided strong leadership, and harmonized quality systems at multiple sites/countries/regions. Vikram has expertise in improving products, processes, systems, and service quality through the implementation of six sigma/continuous improvements/lean tools. He has a proven and successful track record of leading external audits with the FDA, Notified Bodies, and international regulators. He is a passionate and results-driven leader, coach, mentor, trainer, and collaborator with a successful record of staff management and creating strong functional alignments.

Vikram has experience with QMS Integration. He has been responsible for leading Global Quality Excellence teams to deliver QMS tools and systems to harmonize across large manufacturing and design sites to assure compliance, and create effective and efficient procedures and processes, and IT systems. He has successfully developed and deployed a Global Quality Policy & Manual, Design Control, Risk Management, CAPA, NCR, Audits, Management Review, Supplier Controls, and Complaint Handling & Post Market Solutions.

Vikram holds a Bachelor of Science in Mechanical Engineering from the University of Bhopal, India, and a master’s in mechanical engineering from the University of Maryland, College Park.

Areas of Expertise:

• Regulatory Inspections & Audits
• Quality Management Systems
• Executive Leadership and Support
• Mergers and Acquisitions/ Due Diligence
• Supplier Management
• Organizational Transformations
• Global Medical Device Regulations