• Led design transfer for new products to cleanroom production (EOL scope) • Spearheaded MDR documentation reform, specifically Manufacturing Summary in SAP • Managed intercompany transfer of mechanical implant processing across sites • Led IT traceability projects ensuring full batch/material traceability

• Global MDR stream lead, overseeing harmonization for 16+ sites • Standardized documentation per MDR Annex II Part 3, and ensured regulatory readiness • Coordinated global production transfers and led Transfer Quality Plan (TQP) execution • Led design transfer project as per Design Control requirements • Supported site reporting to upper management and advised on corporate engineering strategy

• Owned and maintained process FMEA across global sites under AIAG & VDA methodology • Trained site engineers and quality teams in ISO 14971-compliant risk practices • Supported lifecycle management, internal audits, and new hardware/software deployments • Ensured design and process compliance across multiple concurrent global projects

• Leading DHF remediation and VIMS system alignment post-acquisition. • Harmonized risk management protocols and updated design control elements under Zimmer Biomet SOPs, ISO 13485 and ISO 14971. • Integrated software lifecycle documentation under IEC 62304 for legacy devices • Coordinated cross-functional training and stakeholder buy-in for DHF remediation • Supported global regulatory compliance with EU MDR Annex II/III and FDA 21 CFR 820.30