Amer Ali Mohammed
@ameralimohammed
Mechanical and Quality Engineer driving regulatory-compliant medical device manufacturing improvements.
United StatesWhat I'm looking for
I am an experienced Mechanical and Quality Engineer with 3+ years in medical device manufacturing, skilled in root cause analysis, CAPA, IQ/OQ/PQ validation, and maintaining compliance with FDA 21 CFR Part 820 and ISO 13485. I combine hands-on mechanical design proficiency in AutoCAD, CREO, and Pro-E with strong statistical and process-improvement abilities (SPC, DOE, FMEA) to improve product quality and process capability.
I have led and supported internal and external audits, supplier quality activities, and New Product Introduction (NPI) efforts including PPAP and APQP deliverables, contributing to seamless transitions from development to production. I excel at cross-functional collaboration, developing validation protocols and SOPs, and implementing corrective and preventive actions that reduce variability and ensure regulatory compliance.
Experience
Work history, roles, and key accomplishments
Quality Engineer
Catalent
Aug 2024 - Present (1 year 1 month)
Executed IQ/OQ/PQ protocols and led CAPA investigations to ensure compliance with FDA 21 CFR Part 820 and ISO 13485, improving validation rigour and supplier quality oversight. Supported NPI through PPAP, PFMEA, and control plans while coordinating audits and driving process improvements via DOE and risk assessments.
Quality Engineer
Aurobindo Pharma Ltd
May 2020 - Jun 2022 (2 years 1 month)
Performed IQ/OQ/PQ validations, SPC and FMEA analyses, and managed supplier quality to maintain compliance with FDA and ISO standards, enabling successful product transfers and improved process capability. Led documentation and audit support for DMRs and regulatory inspections.
Graduate Engineer Trainee
Aurobindo Pharma Ltd
Jan 2020 - May 2020 (4 months)
Supported validation activities (IQ/OQ/PQ), conducted root-cause investigations using Fishbone and 5 Whys, and used Minitab and Excel to perform statistical analysis and KPI dashboards that improved supplier performance visibility.
Education
Degrees, certifications, and relevant coursework
JHJawaharlal Nehru Technological University Hyderabad
Bachelor of Engineering, Mechanical Engineering
Bachelor's degree in Mechanical Engineering from JNTUH.
UMUniversity of Central Missouri
Master of Science, Industrial Management
Master's in Industrial Management from the University of Central Missouri.
Tech stack
Software and tools used professionally
Availability
Location
United StatesAuthorized to work in
Job categories
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