Experience

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  Emmar communication

  Jun 2003 - Dec 2005

  System engineer

  • Developed, tested and delivered several CCTV switcher projects.• Understanding the application functionality and fixing bugs in modules developed by other members • Being a part of the bug fixing team during the System Integration Testing and the User Acceptance Testing phases, where the bugs are to be fixed within a short turnaround time.

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  Kone

  Dec 2005 - Nov 2008

  Senior engineer - design

  • Developed, tested and delivered several elevator software projects.• Represented Kone India’s software team in the Kone Global Meet, held in Finland in 2007.• Conducted requirement study & analysis, developed design documents, elevator software, test plan, test cases, RTM & test report and conducted code reviews, unit testing & system testing.• Involved in defect tracking & management, bug fixing and reviewing test protocols.

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  Hcl technologies

  Dec 2008 - Nov 2013

  Associate technical manager

  • Successfully managed & delivered several medical embedded software development and software & system level verification (test) projects• Overall test management that included test strategy development, project planning & execution for medical devices verification.• Spearheaded activities of a team of 10-15 engineers and conducted software development and software & system level verification for various medical devices.• Conducted requirement study & analysis, developed test plan, RTM & verification summary report, performed code & design reviews and conducted unit, integration & system testing.• Planned and monitored development of test protocols & execution of tests.• Involved in defect tracking & management, bug fixing and reviewing test protocols based on understanding of requirements. • Performed software upgrade feasibility analysis for RoHS component replacements. Designed & delivered software for an implantable infusion pump that included IEC-60601-1-8 standards implementation for Alarms through I2C and device driver development for LCD, Real USB & Bluetooth interfaces.• Coordinated with onsite-offshore teams and performed system verification.• Groomed & mentored team members as well as conducted training sessions for them.• Managed process audits and led CAPA activities for various projects. Show less

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  Excellus bcbs

  Apr 2014 - Dec 2014

  Software quality lead

  • Managed system test effort from requirements gathering through project closure, through a risk-based approach and user acceptance test effort (UAT) for multiple insurance projects.• Significantly contributed to the end-to-end cycle of validation from translating business requirements to test requirements through assisting business team with production validation.• Spearheaded activities of a team of 7 test engineers.• Interfaced with legal, compliance, business, release and customer service stakeholders and acted as the QA gate keeper for the release(s) to production. Show less

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  Carestream

  Mar 2015 - May 2016

  Validation lead

  • Managed & delivered multiple software and process validation projects for Carestream Health, a medical devices company.• Owned & delivered validation artifacts (plan, IQ/OQ/PQ protocols & reports) for these projects by working closely with cross-functional teams & vendors.• Managed risk assessment and 21 CFR Part 11 assessment.• Mentored & trained cross-functional teams on validation processes.• Interfaced with multi-project stakeholders & vendors on QMS harmonization. • Created regulation awareness and developed inherent validation requirements and protocols to align with organizational policies, Standard Operating Procedures (SOPs) and Directives (DIRs). Show less

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  Hcl technologies

  Dec 2017 - Jun 2019

  Technical manager

  • Manage & deliver system and software level verification (test) projects for medical devices; spearhead activities of a team of 30 test engineers.• Manage multicultural virtual teams (India & US).• Understand business needs and manage stakeholder expectations.• Deliver projects on time with expected quality and within budget.• Monitor and track project teams' tasks & deliverables.• Communicate progress to customer through daily and weekly reports.• Mentor team members on software test strategies & techniques. Show less

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  Harrison.ai

  May 2019 - Aug 2021

  Quality assurance manager

  Prepared technical file for all phases of Software as a Medical Device (SaMD) Embryo Selection product for TGA regulatory submission. Provided guidance and training to internal stakeholders on quality principles, QMS, GDP & quality processes by strategically supporting QMS establishment for multiple joint ventures.

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  Annalise.ai

  Jan 2020 - Aug 2021

  Quality assurance advisor

  • Established & implemented Quality Assurance as a function & QMS (Quality Management System) from the ground up; delivered Standard Operating Procedures (SOPs), guidance and work instructions that’re compliant with ISO 13485, IEC 62304, EU MDD, TGA, ]FDA, MHRA & AMDD regulations. • Faced ISO 13485 certification audit as the management representative and successfully got ISO 13485 certification for the organization.• Continuously improved Quality Management System (QMS) and change management processes. • Facilitated Artificial Intelligent (AI) model Data labelling, clinical studies and product validation strategies. • Provided guidance to cross-functional teams (including clinical, marketing, customer success and legal) in implementing Medical device best practices. • Monitored & managed risks and compliance via non-conformance and CAPA processes.• Managed Electronic Quality Management System (e-QMS) as the System Administrator. • Managed training needs for the organization including assigning, monitoring & tracking and delivering training for the organization. • Managed supplier qualification and evaluation. Show less

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  Navbit

  Aug 2021 - now

  Head of quality assurance