Sirish S
Engineer
- Role
- Senior Mes Engineer at Johnson & Johnson MedTech
- Location
- Santa Clara, CA, US
- LinkedIn followers
- 500 followers
About Sirish S
Results-driven Quality Engineer with 8 years of experience in the highly regulated medical device manufacturing industry. Proven expertise in ensuring compliance with ISO 13485, FDA regulations (21 CFR Part 820), and GMP standards. Extensive hands-on experience in overseeing manufacturing processes, including process validations (IQ/OQ/PQ), equipment qualification, and production line optimization. Skilled in implementing quality control systems, statistical process control (SPC), and root cause analysis to ensure consistent product quality. Known for a proactive approach to problem-solving, collaborating with cross-functional teams to drive continuous improvement, minimize defects, and ensure product safety and reliability. Adept at leading audits, managing non-conformances, CAPA processes, supplier quality management, and ensuring efficient manufacturing operations while maintaining strict regulatory compliance.
Experience
Senior Mes Engineer
Jan 2025 — Present · Santa Clara, CA, US
Education
Embry-Riddle Aeronautical University
Master's degree, Aeronautics/Aviation/Aerospace Science and Technology, General
2016
Maheshwara Institute of technology JNT University
Bachelor of Technology (B.Tech.), Aeronautical engineering
2008 — 2012
St.Martins High School
SSC, 10th class
1999 — 2006
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