Personal Information
Organization / Workplace
Miami/Fort Lauderdale Area United States
Occupation
Technolaser, LLC
Website
http://www.lasertech-ms.comAbout
1. Have been working in medical device manufacturing (MDM) since 2003 in different roles including: engineering management, manufacturing eng., quality eng., reliability eng., and product/process development.
2. Expertise in process validation IQ, OQ, PQ, PPQ, TMV, DOE, & FMEAs developments, design verification & validation.
3. Experienced in troubleshooting processes for manufacturing Medical devices.
4. Expertise in 21 CFR 820 –Quality System Regulation, 21 CFR Parts 210/211, cGMP and GDP in manufacturing.
5. Expertise in Opto-mechanical design and laser applications, and troubleshooting.
6. Expertise in GD&T and mechanical engineering product support.
7. Post Market Surveillance Proje...
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