Haseeb Bakali
Engineer
- Role
- Quality Engineer at Syncardia Systems, Llc
- Location
- Cincinnati, OH, US
- LinkedIn followers
- 500 followers
About Haseeb Bakali
Haseeb Bakali is an experienced engineer with a comprehensive background in the medical…
Experience
Quality Engineer
Jul 2023 — Present
Served as a scribe during audits for the Temporary Total Artificial Heart, meticulously documenting findings for regulatory adherence.• Developed Regulatory Assessments addressing current leakage testing with the C2 Caddy and closing CAPA requirements, ensuring ISO 13485 and IEC 60601 compliance.• Performed an ISO Gap Assessment to verify compliance with ISO 14708 and ISO 15223 standards.• Reviewed and approved uFMEA, dFMEA, and pFMEA analyses for Total Artificial Heart risk management, transferring comprehensive documentation to Greenlight Guru QMS.• Planned FDA notification strategies to support the removal of pressure requirements within the product.• Organized data for 20+ medical device components in Excel, enhancing visualization for the 2023 Regulatory Submission.
Education
University of Cincinnati - College of Engineering and Applied Science
Undergrad, Biomedical/Medical Engineering
2018 — 2023
University of Cincinnati Carl H. Lindner College of Business
Minor, Marketing
Lakota East High School
High School Diploma
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