Quality Assurance Quality Control Engineer Female Graduate Jobs in Bhopal

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

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