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

  1. Senior Quality Engineer

    Actalent

    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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Ashrah Kalyani — Senior Quality Engineer at Actalent in Canton, MI, US | Unifers