Kishore Thadikonda

About Kishore Thadikonda

18 years extensive experience in Pharmaceutical and medical device testing and software verification and validation, I contribute to ensuring that products meet stringent medical quality and security standards at Roche Sequencing USA. My work is guided by industry benchmarks such as IEC 62304, ISO 13485, and ISO 14971, as I focus on the quality assurance of advanced medical systems. I also collaborate with onsite and offshore teams to resolve challenges and ensure compliance with medical safety standards. Over my career, I have developed in-depth expertise in software Testing lifecycle (STLC), software quality audits, and regulatory compliance in the medical device industry. I specialize in risk management and comprehensive documentation review for software and system testing. My goal is to advance healthcare innovation through rigorous quality assurance and validation processes.

Experience

1. Senior Technical Lead

   HCLTech

   Jul 2022 — Present · Santa Clara, CA, US

   Extensive knowledge on Software quality in Medical Device Industry (i.e, IEC-62304 and FDA Guidelines) Class II or Class devices.• Extensive knowledge on SDLC• Extensive knowledge on Reviewing of S/W Testing Lifecycle.• Knowledge of ALM and SCM such as Helix and Surround.• Experience in reviewing software documentation (requirements, design, test plans, test protocols, test reports)• Experience with regression, impact and dependency analysis.• Medical Device Risk Management knowledge (ISO-14971).• Experience as a software test engineer or system integration engineer (system test, integration test)• Experience performing software quality auditsTypical tasks• Review all documentation generated by software developers and testers includingo Test case initial review / feedback loop for correctionso Software design documentso Requirement updates

Education

• RCM High School, Patibandla,Guntur ,AP

  SSC(1st class to 10th class)

  1987 — 1998

• Dr.Jayapradamba Degree College,Acharya Nagarjuna University,Guntur,AP

  Bsc, Maths,Statistics and Computers

  2000 — 2003

• Bhashyam Junior College,Guntur,AP

  Intermmediate, Mathamatics,Physics, Chemistry

  1998 — 2000

• St. Mary's Group of Institutions,Osmania University

  MCA, Computers

  2003 — 2006

Skills

• 21 Cfr Part 11
• Datacenter Virtualization
• Functional Testing
• Computer System Validation
• User Acceptance Testing
• Quality Auditing
• Healthcare
• System Testing
• Testing