Harsha S
Lead Auditor QMS 13485, Design Quality Engineer working in Quality and Regulatory, Medical Devices
- Role
- Risk Engineer at Phillips Medisize
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
Experience
Risk Engineer
Dec 2023 — Present · Bengaluru, IN
Lead device risk frameworks aligned with ISO 14971:2019 and site SOPs for Insulin Pen and GLP-1 injector variants.• Own and maintain Risk Management documentation for Stage-Gate Deliverables.• Performed in‑depth reviews of usability files and task analysis, evaluating step‑by‑step user interactions.• Ensured all critical tasks were accurately identified, documented, and traced to risk management files and design mitigations.• Reviewed DVT, BER, and other verification reports to confirm proper implementation and effectiveness of risk control measures, ensuring traceability to Hazard Traceability Matrix.• Reviewed Threshold Analyses for combination devices (drug–device products) to determine the regulatory impact of design and process changes.• Drive regular Stage-Gate Risk Reviews with cross-functional teams, including Human Factors, Systems, Manufacturing, and Quality.• Drive reliability ownership, validating Reliability Budgets with ECT data and ensuring design endurance and robustness.• Developed internal statistics forums and conduct training workshops on statistical tools and reliability methodologies.• Contributes to reliability model development for emergency-use devices.
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