Exploratory Testing, Pytest, Mobile Device Testing, Agile Methodologies, Python, Iso 13485, scenario-based manual testing, IEC 62304, Boundary Value Analysis, Playwright, test design techniques, Decision Table Testing, end-to-end testing, Equivalence Partitioning, Error Guessing, State Transition Testing

Design History File Compilation, Technical File Documentation, Design Verification, Quality Tools, usability engineering, Statistical Methods, Risk Management, Post Market Surveillance, ISO 13485 Quality Standard, Complaint Investigation, MDD, IEC EN 62366, 21 CFR 4 Regulation of Combination Products, Quality Risk Management, Process Qualification and Validation, Corrective Action and Preventive Action System, MDR, Test Procedure Development, Design Control Activities, ANSI HE75 Human Factors Engineering

Iso 14971, Collaboration, IEC 62366-1, usability engineering, human factors engineering, Risk Management, Technical Writing

Quality Management System (QMS, Atlassian Tools (JIRA, Confluence, Test Automation, Bamboo, Verification And Validation, Software Testing, System Testing, Test Engineering, AWS, Redis, Python, Azure, Mongo, Cloud Infrastructure Verification, AMQ, Iso 13485, Iso 14971, Helix Jama, Polarion, GPI Databases, Cloud Certificates, IEC 60601, IEC 62304, Salesforce applications, Aurora

complaint investigations , regulatory audits , Technical documentation systems, Iso 13485, fmeca, Post-market surveillance, Fmea, quality engineering, Root cause analysis tools, ISO 14971 risk management frameworks, Medical device systems engineering, Data analysis tools, Complex electromechanical devices, Hazard Analysis, NCR CAPA and deviation management systems, Complaint handling and investigation workflows, 21 CFR Part 803 Medical Device Reporting, Robotic medical device experience, Adverse event investigations, fault tree analysis, FDA inspections, 21 CFR Part 820 QSR

statistical analysis techniques, Iso 14971, US FDA 21 CFR Part 820, Iso 13485, risk management methodologies

Scaled Agile Framework (SAFe), Katalon, Gxp, Agile Development Methodologies, Sql, Jenkins, Typescript, 21 Cfr Part 11, Javascript, Selenium, Restful Apis, Azure DevOps, Cloud Technologies, Playwright, DevOps practices, GitHub Actions, Cypress, AI-assisted software testing, Test case and defect management tools, Polarion, CI/CD pipelines, Microservices-based architectures, Regulated software development environments, end-to-end testing

21 Cfr Part 11, Testing, Körber PAS-X, data integrity, Emerson Syncade, Annex 11, Gmp, Validation, GAMP5, electronic batch records, Siemens Opcenter

supplier negotiation , SAP, MS Dynamics, Oracle, COGS tracking, Iso 13485, Data Analysis, Excel reporting tools, ERP systems, contract management, Sourcing Strategy

ERP systems - Oracle or SAP, Lean Manufacturing, Design change and implementation, Iso 13485, Validation and qualification risk assessment, Manufacturing process engineering