Validation Verification Engineer Lead - Medical Devices Orthopaedic Implants Company Evolortho Tech Pvt Ltd Location Manufacturing Facility - Bangalore Reporting To QARA manager Department Quality Assurance Regulatory Compliance Design Development Job Purpose To plan execute and document validation and verification V V activities for orthopaedic implants and associated instruments to ensure compliance with ISO 13485 MDR 2017 21 CFR Part 820 QSR and Indian CDSCO requirements The engineer will ensure that products with existing predicates meet design process and performance equivalence through robust testing and documentation aligned with Design History File DHF and Device Master Record DMR requirements Key Responsibilities 1 Develop and execute validation and verification V V plans aligned with design inputs risk management ISO 14971 and regulatory requirements 2 Conduct design verification protocols - dimensional mechanical fatigue corrosion and biocompatibility tests per ASTM and ISO standards 3 Perform process validation IQ OQ PQ for machining polishing cleaning passivation and packaging operations 4 Support software tool validation where relevant e g CAD CAM CNC inspection systems 5 Prepare and maintain validation protocols reports and traceability matrices ensuring compliance with ISO 13485 and 21 CFR 820 75 6 Coordinate with cross-functional teams R D QA Production and external laboratories for validation tests 7 Assist in DHF and DMR documentation and ensure alignment with predicate device evidence 8 Support risk management FMEA and CAPA implementation ensuring revalidation where required 9 Participate in internal external audits ISO 13485 CDSCO MDSAP and ensure readiness and closure of non-conformances Key Skills Competencies 1 Thorough understanding of medical device validation principles Design Process Cleaning Sterilization 2 Knowledge of ISO 13485 ISO 14971 ISO 10993 ASTM F136 F138 F75 ISO 7206 and ISO 14242 standards 3 Experience in protocol drafting data analysis and statistical tools MSA Cpk GR R Minitab 4 Strong documentation analytical and report writing skills 5 Understanding of predicate comparison and equivalence demonstration principles 6 Excellent coordination communication and audit-readiness skills Education Qualification Bachelor s Master s Degree in Biomedical Engineering Mechanical Engineering Experience Required 3-7 years of experience in medical device manufacturing or orthopaedic implant validation Prior experience with predicate-based devices CDSCO preferred Experience in design verification process validation and regulatory documentation is essential Exposure to cleanroom processes sterilization validation and biocompatibility test coordination desirable Certifications Preferred ISO 13485 2016 Lead Auditor Internal Auditor Six Sigma Green Belt Validation Statistical Tools Training in Risk Management ISO 14971 MDR 2017 EU MDR Awareness Training Career PathValidation Engineer Senior Validation Engineer Quality Regulatory Lead Quality Assurance Manager Regulatory Affairs Job Types Full-time Permanent Pay 500 000 00 - 1 500 000 00 per year Advantages Cell phone reimbursement Commuter assistance Food provided Health insurance Provident Fund Work Location In person

📌 Validation Engineer (Karnataka)
🏢 Indaco Metal Coats
📍 Karnataka