Anand Xavier

About Anand Xavier

An innovative, methodical, detail-oriented and quality driven Quality Engineering Director with over 20 years of proven people management experience, who efficiently developed, implemented and managed effective quality control processes with expertise and experience in:• Global Quality Strategy & Project Management• Strategic Planning & Talent Management• New Product Development & Design Transfers• Continuous Improvement – LEAN & DMAIC• CAPA & Complaint Management• Risk Management, Process Validation & SPC/Statistics• Supplier Management & Third-Party Manufacturing Audits• Acquisitions, Transfers & Product Lifecycle Management• External Audits (MDSAP, FDA, UKCA, ANVISA, INMETRO, PMDA and CAN/CSA)• External Standards (ISO 13485, EUMDR, 21CFR820 and IEC 60601)

Experience

1. Director of Quality

   Abbott

   Oct 2021 — Present · US

   Managed multi-site teams as the Quality Management Representative (QMR) with PRRC responsibilities to drive division-wide quality compliance culture and continuous improvement across sites.• Directed strategic executive leadership initiative to improve quality efficiency, talent development, and embed growth culture reducing employee turnover by 30% and strengthening talent pipeline.• Partnered with executive leadership to communicate quality vision and drive cross-functional alignment across Electrophysiology division, resulting in improved compliance and operational efficiency.• Led cross-functional process optimization Kaizen events to improve site quality inspection and product release efficiency by 20%.• Spearheaded Health Hazard Evaluations (HHE), risk mitigation strategies, and field actions as a core team leader driving decisive actions to minimize business impact.• Served as Divisional CAPA leader for various multi-site compliance improvements to implement effective production and process controls to attain 15% reduction in human-related causes.• Led multi-site New Product Development teams in launching/sustaining Class medical devices (ICE, diagnostic and ablation catheters) achieving cost reduction, EUMDR compliance, and enhanced process capability through risk-based validations and SPC.• Directed multi-site software teams to ensure FDA-compliant data integrity, mitigate cybersecurity risks, and validate non-product software per 21 CFR Part 11 and cybersecurity requirements.• Managed corporate-wide teams for electronic DHR system – Manufacturing Execution System (MES) implementation across multiple divisions to improve efficiency and quality data compliance.• Established quality improvement plans, led operational reviews, and defined objectives to enhance compliance and ensure global audit readiness across division.• Effectively managed multi-site MDSAP, FDA, CFDA, PMDA, ANVISA, INMETRO and IEC60601 audits, achieving compliance.

Education

• Isenberg School of Management, UMass Amherst

  Master of Business Administration (MBA), Operations Management and Supervision

• Bharathiar University

  Bachelor of Engineering (B.E.), Electronics and Instrumentation Engineering

• University of Miami

  Masters, Biomedical Engineering

• University at Buffalo

  Masters, Electrical Engineering

Skills

• Spc
• Root Cause Analysis
• Medical Devices
• Capa
• Minitab
• Design of Experiments
• 21 Cfr
• Design Control
• Quality Assurance
• Supplier Quality
• Iso 14971
• Validation
• Quality System
• V&V
• Biomedical Engineering
• Fda
• Six Sigma
• Iso 13485