Medical Device Specialist
- Risk-based analysis FMEA and remediation across multiple products including implants, combination drug/medical devices
- Bill of Material Structure and Device Master Record Structure
- Design History File Structure
- Medical Device Software and Software Applications
- Design for Manufacturability and Cost Reduction Opportunities
- Safety Event Reports of Investigational and Marketed Drugs/Medicinals
- EU Medicinal Dossier Design and Preparation
- ISO 13485:2016 Medical Devices - Quality Management Systems (QMS)
- ISO 14971:2019 Medical Devices - Application of Risk Management to Medical devices
- Safety Reporting (Complaints, Medical Device and Manufacturer Incident Reports (MDR and MIR)
- Field Action (Recalls/Corrections/Removals) and Stock Recovery Systems Planning and Execution