Aakash B
Quality Engineer at Amgen
Hopatcong, New Jersey, United States
Summary
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Senior🎓
Top SchoolAakash B is a Quality Engineer with 11 years of experience specializing in medical device manufacturing, plastics and silicon injection molding, and regulatory compliance. He has deep expertise producing validation deliverables (IQ/OQ/PQ, DHFs, validation plans, TMV), risk management (DFMEA/PFMEA), and navigating 21 CFR Part 11, cGxP and GAMP requirements. At Amgen, Stryker and BD he led supplier quality, CAPA/SCAR programs, PPAPs and statistical process controls using DOE and Minitab to drive measurable process improvements. He pairs lean manufacturing tools (Kaizen, 5S, JIT) with strong root cause analysis skills to reduce waste, lower material costs, and resolve nonconformances through MRB/CAPA. Comfortable with engineering change control, drawing standards (ASME Y14.5/24) and clinical/design verification workflows, he also brings hands-on experience preparing device history and regulatory gap remediation plans. A lifelong learner who describes himself as curious and exploratory, he blends practical shop-floor know-how with structured regulatory rigor to bring new products to market safely and efficiently.
11 years of coding experience
4 years of employment as a software developer
Master's degree, Mechanical Engineering, 3.8, Master's degree, Mechanical Engineering, 3.8 at Texas A&M University-KingsvilleBachelor's degree, Mechanical Engineering, Bachelor's degree, Mechanical Engineering at Easwari Engineering College(SRM Group)
Github Skills (4)
mobile-application2
java2
ios1
broadcast1
Github contributions (5)
aakash5454/codex
Apr 2015 - Mar 2017
Contributions:1 PR, 19 pushes, 1 branch in 1 year 11 months
lawssnippets
aakash5454/iCalPlus
Mar 2015 - Aug 2015
Contributions:27 commits, 20 pushes, 1 branch in 4 months
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