Quality Assurance Engineer Job Vacancies in Bhopal

Job descriptionAtDo iT Leanwe believe that with the right people, process and technology good things happen. But our people are what makes us great. That's the reason why we are looking for more talented and motivated people that are passionate about technology, customer-driven, and interested in working in a growing and challenging place where new ideas and trends thrive.Job Requirements:1. 2-5 years of experience as a Software Tester.2. Strong analytical and problem-solving abilities.3. Good written and verbal communication skills.4. Solid understanding of STLC.5. Hands-on experience with Functional, API, Integration, Regression, UI/UX, and Compatibility Testing.6. Knowledge of test automation.7. Good if worked on Mobile Application Testing.8. Good knowledge of defect reporting tools like JIRA, Mantis, and ALM.9. With good knowledge of DB, a candidate should have verified the project/product at the database level.10. Working experience on Agile and V-Model methodology.11. ISTQB certification is a plus.12. Degree in Computer Science or relevant fields.Job Responsibilities:1. Review and analyze system specifications or required documents in detail2. Collaborate with team to develop effective strategies, test scenarios, and plans3. Execute test cases (manual or automated) and analyze results4. Create logs to document testing phases and defects5. Report bugs and errors to development teams and help troubleshoot issues6. Conduct post-release/ post-implementation testing7. Work with cross-functional teams to ensure quality throughout the software development lifecycle

Should report to the Quality/production manager.Supporting the senior manager in research and development.Recording and analyzing data.Collecting, preparing, and/or testing samples.Maintaining, calibrating, cleaning, and testing sterility of the lab equipment.Providing technical support to senior managerPresenting results to senior manager.

Key ResponsibilitiesQuality AssuranceDevelop, implement, and maintain Quality Management Systems (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable standards.Conduct internal audits, CAPA (Corrective & Preventive Action), and risk assessments to ensure ongoing compliance.Monitor production processes and verify adherence to SOPs, specifications, and quality standards.Quality ControlPerform in-process inspections, final product testing, and release of products.Review and approve batch records, test reports, and other QC documentation.Manage calibration and preventive maintenance schedules for testing and measuring instruments.Investigate non-conformities and implement corrective actions.Regulatory ComplianceEnsure compliance with national and international medical device regulations (FDA, CDSCO, CE, ISO).Support preparation of regulatory submissions (510(k), PMA, CE Marking, etc.).Communicate with regulatory authorities to resolve compliance issues.Process ImprovementIdentify areas of process improvement to enhance product quality and operational efficiency.Implement Lean Six Sigma/continuous improvement methodologies to reduce defects and improve productivity.Supplier Quality ManagementConduct supplier audits and ensure raw material/component quality.Collaborate with vendors for corrective actions and quality improvement initiatives.Documentation & ReportingPrepare and maintain technical files, Device Master Records (DMR), and Device History Records (DHR).Maintain up-to-date documentation to support internal audits, external inspections, and certifications.Generate quality reports and present trends to management for decision-making.Required Skills & KnowledgeStrong understanding of QA/QC principles in the medical device industry.Knowledge of ISO 13485, ISO 14971, GMP, and FDA 21 CFR Part 820.Hands-on experience with quality audits, validation, and verification processes.Familiarity with regulatory submissions and compliance requirements.Excellent documentation, analytical, and problem-solving skills.Ability to train and guide cross-functional teams on quality and compliance. WhatsApp: +91 9266682964

Designing on solidworks & Autocad. Inspection of jobs on machine. New job study & production setup. Job record of machines. Final inspection report of jobs & packaging

Candidates should be relevant experience in sheet metal fabrication industry Should be good in English languages