Akshay Naigaonkar
email--call- (INDIA) - (WhatsApp)
Six Sigma, PMP, CSQA, CMMI, ISO9001, ISO13485, Agile SCRUM, PMO, HITRUST, ITIL
Objective
Open to work at senior profile in Process Excellence or Project Management or Consulting
- in the software development (R&D), data operations, compliance and quality management
- in a data driven and/or Cloud technology / Healthcare company / Information Security
- in the area of process improvement using ISO/CMMI/ITIL/Agile/Six Sigma/Cyber Security
Summary of Experience
Passionately driving the process excellence, continuous process improvements, compliance management,
project management (PMO) for around 20yrs now. Proven track record of effective governance and project
management and process improvements in IT projects in domains like Healthcare industry, Insurance,
Medical devices, Mobile communication, data operations etc. Worked on cloud based products, latest
technology trends. Highly skilled at developing streamlined processes, and driving org-compliance.
Leading by example and coaching process excellence across functional teams.
Various quality initiatives:
HITRUST & Cyber Security Management implementation for cloud platforms like GCP & AWS
Implemented GRC compliance, Data Privacy investigation, HIPAA, GDPR Implementation
Implementation of CMMI-Dev (V1.1, 1.2, 1.3) level5 High maturity processes
Lean and Six Sigma process improvement projects
Statistical Process Control SPC, Quantitative Project Management QPM
QMS Internal Auditor, Process Compliance Auditor for ISO 9001, ISO13485, ISO27001
Project / Product/ Process Quality Metrics, Dashboards and Reporting
Educational Qualification
MBA (IT Systems) passed in 2015, passed from Pune University
B. Tech. Chemical Technology passed in 2003, from Nagpur University.
Diploma in Computer Programming & System Analysis (Vocational Course)
Certifications
Trainings
Six Sigma Black Belt (BB-09)
Software Quality Analyst CSQA
Project Management Professional (PMP)
Certified ITIL Foundation V4
AWS Certified Solutions Architect – Associate
DevOps Architect Master’s
GDPR Awareness Training
HIPAA Awareness Training
‘Introduction to CMMI’
ISO Internal Auditor ISO 27001
JIRA Reporting and Dashboards
Cyber Security & Ethical Hacking
PMP Certification Exam Prep course
Employment History
Sr. No
Employer
Role
Start
End
1
FIGmd (India) Pvt. Ltd
Manager Process & Quality
Apr 18
Sep 23
2
Capgemini Technology Services
Consultant – PMO
May 13
Apr 18
3
Cybage Software Pvt. Ltd
Manager- Process
Dec11
May 13
4
Larsen&Toubro Infotech Limited
Senior Engineer Quality Leader
Dec 06
Nov 11
5
Rolta India Ltd
Executive – SQA
Feb 06
Dec 06
6
Other Jobs
Quality Engineer
Jan 04
Feb 06
Akshay Naigaonkar Resume Page 1 of 4
Akshay Naigaonkar
email--call- (INDIA) - (WhatsApp)
Six Sigma, PMP, CSQA, CMMI, ISO9001, ISO13485, Agile SCRUM, PMO, HITRUST, ITIL
Work Experience & Assignments
FIGmd from Apr18- Sep23
Project2: FIGmd Data Operations Management
Duration: From Apr2018 till Sep2023
Role: DataOps Management - PMO
• Worked for Healthcare Data Management and Various Healthcare Registries. Acted as IT Security,
Process and Quality Manager for Ops, ETL, Mapping team, Data Operations management (DataOps)
and Customer CAS teams
• Developed and submitted CMS approved Quality Payment Program (QPP) measures for Qualified
QCDR Registries. Planned and managed customer submission process activities, data operations
and data submission activities. Planned and managed Deployments of registry specific measures,
refinements, platform product enhancements
• Delivery & Operations Coordination: Implementing Cyber Security policies and processes, GDPR,
HIPAA requirements, managing customer feedback (Refinements), non-compliance, defects and
data issues and data processing challenges, assisting in corrective & preventive actions.
• Process Audits: Identified and reduced incident (includes Cyber security incidents, privacy
compliance notifications - breaches) opportunities, issues, deviations, and bugs/defects by auditing
processed and improving workflows, eliminating waste, and removing process bottlenecks. Thus,
helping DataOps teams in data accuracy & on-time dashboard delivery. Conducted weekly work
product review, monthly IT Access Reviews, process audits for functional and data-ops teams.
• Designed and developed Google DataStudio reports, Jira Dashboards, Automated Status Reports
and provided clear visibility to senior management, and across the various functional groups.
Project1: HITRUST (Cyber Security) & GDPR (Data Privacy) compliance implementation
Duration: From Apr2018 till Sep 2020
Role: Process, Quality & Compliance Consultant
• Assessment and Gap Analysis, Policy and Procedure Development, Performing Risk Management,
Training and Awareness, Coordinating for Technical Controls Implementation, implementing
Security Incident Response, Internal ISMS audits and Documentation, Coordinating Third-Party
Risk Management, Continuous Monitoring and Improvement
• Assessment and Gap Analysis:
Conducted comprehensive assessment of the current security posture. Identified gaps between
current practices and HITRUST CSF requirements and distilled HITRUST & GDPR compliance
requirements into product requirements.
• Policy and Procedure Development: Created and updated policies and procedures to align with
HITRUST CSF for Cyber Security practices. Ensured that all the policies are documented well and
updated as necessary. Designed and developed IT Security Management policies, processes, SOPs,
guidelines and process assets using Confluence.
• Training and Awareness: Conducted training sessions for employees on HITRUST requirements and
security best practices to raise the awareness about the importance of compliance and security
across organization. Coached project managers, delivery managers, operations, products teams for
HIPAA and GDPR compliance, IT Security management and process adherence using Jira
• Administered the Confluence space & Jira project for HITRUST governance and project planning
and HITRUST project management.
Akshay Naigaonkar Resume Page 2 of 4
Akshay Naigaonkar
email--call- (INDIA) - (WhatsApp)
Six Sigma, PMP, CSQA, CMMI, ISO9001, ISO13485, Agile SCRUM, PMO, HITRUST, ITIL
Capgemini from May13- Apr18
Project2: Agile Coach / Scrum Manager (Medical Device Software Design & Development)
Duration: From Apr2015 till Apr 2018
Role: Process Consultant cum Agile SCRUM Manager cum Jira Administrator (
• Implemented IEC62304 medical device software development processes and implementing QMS
(ISO13485) requirements in the projects.
• Acted as a servant leader, and agile coach, SCRUM Manager, SPOC for Jira & SCRUM.
• Processes and SCRUM management using end-to-end Jira implementation
• Steer headed product (software) quality metrics and non-compliances, improvements and
innovations in product, processes and services.
• Helped product owner migrating product requirements into User Stories & formulating release
plans, product backlogs & User Stories, Sprint scopes, requirements changes and Assurance cases.
• Designed and developed SCRUM processes using Jira. Custodian for the agile SCRUM processes
Tools used: JIRA, and Bug tracking system (TestTrack) and Code Review Tool (Code Collaborator), Static
Code Analyzer (PRQA), Vector Cast Unit Testing, MasterControl etc used for product software
development, Python scripting for automating data collection and metrics analysis.
JIRA Administration & other tools administration- administered JIRA (Core and Software), Confluence,
data backups and scheduled jobs. JIRA projects, workflows, screens, fields, schemes and reporting and
users setting and permissions, SCRUM Boards and Dashboards.
Project1: PMO group Management for P&ES Group
Duration: From May2013 till Apr 2015
Role: PMO Consultant for Medical Devices Design & Development Business Unit
• Identified Risky projects based on key KPI
• Conducted project reviews
• Provided training, coaching, mentoring on project management and quality management principles
• Implemented metrics and KPI program and PMO processes for medical devices business unit
• Ensured adherence to the project management practices, scrum principles, Regulatory
requirements and compliance requirements
• Implemented shared learnings and best practices across medical devices group
As a PMO Specialist carried out quality improvements, BU-level program governance, and delivery
compliance, and supported in financial and resource management activities during the program life cycle.
Facilitated and conducted project review & improvements across the business unit.
Cybage from Dec2011- May2013
Project1: Process Excellence and CMMI implementation
Duration: From Dec2011 till May2013
Role: Process Manager
• Implemented CMMI High Maturity process areas like Organizational Process Performance and
Quantitative Project Management, SEPG program. Key Roles and responsibilities:
o To create, update and analyze Process performance baselines to bring improvement
o To guide and mentor the SQA team members for CMMI implementation
o To train project managers and other group members on CMMI model implementation
o To drive process compliance in projects and find QMS implementation gaps
o To guide projects in implementation of prediction models, SPC and process innovations
o To drive SEPG group activities and drive process improvements and to improve QMS
Process asset library document
• Designed and developed a sustainable process audit framework using MS TFS covering end-to-end
process review, process and work product audits, reporting and closure tracking.
Akshay Naigaonkar Resume Page 3 of 4
Akshay Naigaonkar
email--call- (INDIA) - (WhatsApp)
Six Sigma, PMP, CSQA, CMMI, ISO9001, ISO13485, Agile SCRUM, PMO, HITRUST, ITIL
L&T Infotech from Dec2006- Nov2011
Project2: Software Quality Assurance (onsite Major Mobile Manufacturing company in Japan)
Duration: From Mar 2009- Sep2010
Role: SQA (Software Quality Analyst) and Data Analyst
SQA and PMO Activities for Mobile Product Platform and Application Software:
• SW KPI definition and project status tracking against each KPI.
• Project metrics framework development based on data driven queries from defect database, excel
based templates, preparing project status report and standard format.
• Return Rate analysis: Quantitative estimations
• Data mining/ data analysis using various in-house, commercial data analysis, data mining tools for
defects data, Coverity, crash and MTBC data, Product Returned Analysis using Qlikview
Project1: Process Excellence and Organisation Quality Process implementation
Duration: From Dec 2006- Nov2011 (Excluding Onsite period)
Duration: Quality Leader for Insurance Business Unit- Software development, Maintenance and Testing
Some of the regular activities were:
• Preparing Quality Planner, Conducting Process Audits & Work Product Audits, Cyber security Audits.
Report audit findings, calculating process compliance, their closure. Follow up on corrective actions
and suggesting the improvements in the project. Intermediate review of the processes, practices.
• To implementing the CMMI level 5, SAS70, ISO9001, ISO27001, IT security and Cyber security
processes in projects. Ensuring Process compliance in the projects, escalation if required. To help
project in estimation, metrics, using best practices, and project closure.
Some of the Improvements done in the projects
• Implemented Statistical process control and project metrics base lining and predictions Prepared
metrics action plan (MAP) and template for Independent Testing Project projects, Release based
projects and Maintenance projects
• Process/ artifacts/ templates improvement - Prepared and updated Excel, Word based templates
for capturing data and building Organizational process assets and its improvements
• Actively participated in SEPG activities such as various QMS testing and roles specific QMS
Trainings, Training coordination, suggestion verification etc.
• Quality assurance of various .Net projects work-product audits and insurance domain
• Implemented Taguchi system (Orthogonal test cases) concepts in one of the account for reducing
number of test cases successfully
• Improvement Results in testing: increased productivity and early defect detection.
Other and Responsibilities in the previous organizations
• CMMI SCAMPI A/ SCAMPI B: – ATM (Assessment Team Member): SCAMPI A & SCAMPI B, for CMMI
level 5 assessment.
• Involved as Core team member in ISO27001 certification: As a part of IT security Task Force,
implemented IT/Cyber security controls for organization and conducted Internal IT security audits.
Personal Information
Nationality: Indian & Language: English, Hindi, Marathi
Permanent Address: C403, Rainbow Vissta, Ravet, Pune 412101 (INDIA)
Alternative email id:-, Alternative Contact: -
Online Presence
LinkedIn: https://linkedin.com/in/akshay-naigaonkar
Github: https://github.com/akshaysn80
Akshay Naigaonkar Resume Page 4 of 4
