Ashrah Kalyani
- Role
- Senior Quality Engineer at Actalent
- Location
- Canton, MI, US
- LinkedIn followers
- 500 followers
About Ashrah Kalyani
Master-level Six-Sigma certified Biomedical Engineer and MBA grad! Currently working as a…
Experience
Senior Quality Engineer
Apr 2021 — Present
Senior Design Quality Engineer - Exactech (May 2022-Present) • Working on Gap Analysis, DHF Remediation activities and ensuring compliance with FDA regulations • Performing Design Reviews; Performance and Durability Requirements such as test method validation and sample size justification; Verification of simulation documentations; Review of evaluation methods, user needs, and equivalency review; Compatibility Reviews for First Article Inspection, Test Protocols and Reports, Physical Tests, Deviations. Senior Quality Engineer- Arthrex (April 2021-April 2022) • Managed acquisition and integration project • Worked on Gap Analysis, DHF Remediations, Design Trace Matrix, Review of Design input/ output rerequirements to make sure it complies with 21 CFR Part 820. • Tracked and Trended deliverables to assess overall health and progress of the deliverables and the projects • Led the Quality Engineer and acting as a client liaison to make sure project gets executed in a timely manner.
Skills
- Radiation Therapy
- Matlab
- Radiation Protection
- Mri
- Elisa
- Clinical Trials
- Biomedical Engineering
- Instrumentation
- Medical Devices
- Biochemistry
- Mathematical Modeling
- Medical Imaging
- Molecular Biology
- Cancer
- Engineering
- Bioinformatics
- Medicine
- Hospitals
- Clinical Engineering
- Fda
- Data Analysis
- Biotechnology
- Healthcare
- Clinical Research
- Research
- Autocad
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