Marijose Sanchez Email & Phone Number

Austin, Tx, Us

- Executed remediation activities to update Design History Files (DHF) deliverables for assigned products to ensure compliance with relevant regulations, standards, and quality management system procedures (21CFR820, ISO 13485, and ISO 14971).- Developed design control traceability management to establish user needs, design input requirements, design outputs, and design verification and validation activities.- Created Risk Management Plans and applied risk management methods such as Hazard Analysis and Design Failure Modes and Effects Analysis (DFMEA) to estimate and evaluate failure and mitigate risk.- Managed timelines and served as a project lead for multiple projects at once in order to achieve team and company goals.- Created protocols and biocompatibility plans for product testing.- Collaborated with Medical Affairs, Regulatory Affairs, Regulatory Science, Quality Engineers, Global Product Managers, External and Internal Project Supports, and External Testing Labs.

San Antonio, Texas Metropolitan Area