krish rao

Led Quality Systems as SME during 4+ successful regulatory audits (MDSAP, MDR), achieving 100% compliance with no major findings. Owned and enhanced Quality Management System (QMS) processes, improving procedural efficiency and audit readiness across functions. Directed cross-functional CAPA & NCIR processes, leading root cause investigations and implementing systemic actions that reduced recurren

Collaborated with Regulatory Affairs and Engineering to generate MDR-compliant technical files and ISO 14971 aligned Risk Management documentation, supporting 10+ product model submissions. Supported internal audits & pre-certification assessments, remediating findings by CAPA plans and ensuring long-term compliance. Authored and validated 20+ Test Methods and associated TMVs, enabling consistent

Performed gap assessments and reviews on existing processes and procedures to ensure compliance with new/updated standards. Conducted comprehensive reviews of 100+ design and risk documents to ensure conformance with ISO 13485/EU MDR requirements. Authored, reviewed 5+ SOPs and developed document control review checklists for 18 types of quality/design control documentation.

Audited 3+ supplier quality, process capabilities and established rubrics to evaluate part quality for outsourcing pallet manufacturing. Achieved $16K capital savings through reuse of old inventory pallets by design modifications and resolved non conformances for parts. Negotiated agreement terms, clauses for 5+ contracts through RFQ’s and process capability concerns to lower total capital costs.

Gained 14% potential cost benefit by integrating 5 parts into a single subassembly for reducing device manufacturing & assembly time. Spearheaded quality improvement projects by manufacturing process changes & 3D CAD part redesign in Class II & III medical devices. Supported Engineering studies and Supplier Process Change Request (SPCRs) per design updates to component, top level design changes.

Grade: 3.87/4.0

Pursued advanced studies in engineering and business management. Focused on leadership, operations, and strategic decision-making within technical organizations.

Grade: 3.5/4.0

Completed foundational coursework in mechanical engineering principles. Studied topics including thermodynamics, mechanics, and materials science.