Shayan Gerami
Quality Engineer @ Flex | Lean Six Sigma, Biomedical Engineering
- Role
- Opertional Quality Engineer (Iii) at Flex
- Location
- Austin, TX, US
- LinkedIn followers
- 500 followers
About Shayan Gerami
Possible summary:As a Senior Quality Operational Engineer at Flex, I apply my expertise in quality management and problem-solving to uphold the highest safety and performance standards, ensuring the production of safe products while increasing yield processes. I achieve this by analyzing data to identify gaps and implementing strategies to address them. Working closely with engineers, technicians, and Supplier Quality teams, I focus on effectively enhancing processes. Additionally, I play a vital role in the continuous improvement of our quality processes and procedures by leading initiatives related to Non-Conformance Material Reports (NCMR), Corrective and Preventive Actions (CAPA), and deviation activities.I am passionate about applying my engineering skills and knowledge to the healthcare sector, where I can make a positive impact on people\'s lives and well-being. I am always eager to learn new skills and technologies, and to enhance my professional development. I am looking for opportunities to leverage my competencies and to expand my network in the biomedical and robotics fields.
Experience
Opertional Quality Engineer (Iii)
Dec 2023 — Present · Austin, TX, US
Experienced in Non-Conformance Material Review (NCMR) under ISO 13485 and 21 CFR Part 820 standards. Proficient in Corrective and Preventive Action (CAPA) and process improvement initiatives, closely collaborating with customers to address any quality issues related to product, process, or documentation. Skilled in managing projects aimed at enhancing processes, procedures, and overall quality. • Collaborate with supplier quality teams and customers to address material-related issues, including resolving discrepancies in specifications. • Experienced in deviation handling, ensuring GMP compliance during walk-throughs and supporting preparation for audits. • Lead quality-focused initiatives across factory segments, managing rapid response meetings for immediate issue resolution. • Support the Device History Record (DHR) team in streamlining processes to enhance efficiency and compliance.Dedicated to ensuring product quality, maintaining regulatory compliance, and fostering continuous improvement across all facets of manufacturing and quality control.
Education
Texas Southern University
Pharmacy Technician/Assistant
Texas A&M University
Master of Engineering - MEng, Biomedical/Medical Engineering
2020 — 2021
Texas A&M University
Bachelor's degree, Biomedical/Medical Engineering
2017 — 2020
Houston City College
Associate of Science - AS, Biology, General
2014 — 2017
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