Abhilash Anuganti
Quality Assurance Leader | MedTech, SaMD, & Life Sciences Domain Expert | ISO 13485 Lead Auditor | CSV / CSA | Cyber Security | Driving Compliance, Innovation, and Regulatory Excellence
- Role
- Functional Consulting Lead at EPAM Systems
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Abhilash Anuganti
Abhilash Anuganti is a Quality Management (QMS) and Computerized System Validation (CSV)…
Experience
Functional Consulting Lead
Apr 2024 — Present · Hyderabad, IN
Leading the Quality stance for MedTech Client with Class devices by defining and driving the end-to-end validation and compliance strategy for a Digital Health Platform (DHP) on Azure cloud, from design through FDA Real Time Review (RTR) submission.Establishing risk-based validation frameworks and regulatory guardrails for Azure-hosted systems, ensuring HIPAA, GDPR, ISO 13485, and 21 CFR Part 11/820 compliance.Facilitating cross-functional discussions with client Quality, Engineering, and Regulatory teams to enable informed decision-making on architecture, cybersecurity, and validation priorities.Imparting targeted trainings on QMS, regulatory requirement, and validation best practices, fostering a strong quality mindset across delivery teams and stakeholders.Driving creation of minimum deliverables, traceability matrices, and cybersecurity controls to ensure smooth submissions, and audit readiness.Championing continuous QMS improvements, quality engagement in mutli-pod work streams, agile quality practices, and Kanban-based governance catering to delivery, reduce compliance risk, and accelerate market readiness.
Education
BITS Pilani
Masters Degree
2012 — 2014
Sri Chaitanya High School
Schooling
2001 — 2004
Jawaharlal Nehru Technological University Hyderabad (JNTUH)
B.Tech
2006 — 2010
Indian Statistical Institute (SQC & OR)
Six Sigma Master Black Belt with Business Analytics | Statistical Quality Control
2017 — 2018
Skills
- Program Management
- Regression Analysis
- Requirements Analysis
- Do254
- Agile Methodologies
- Quality Assurance
- Human Resource Planning
- Do-178b
- Soi-3
- Iso 9000
- Six Sigma
- Sdlc
- Project Management
- Software Quality Assurance
- Capability Maturity Model Integration (Cmmi)
- Team Management
- Avionics
- Tqm
- Information Security Management
- Software Project Management
- Quality Management
- Social Networking
- Do178b
- Cmmi
- Utc - Ace
- Software Development Life Cycle (Sdlc)
- Iso 9001:2008
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