Kailash Kalidoss
Senior Quality Engineer @THINK Surgical
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WORK HISTORY
Senior Quality Engineer @THINK Surgical
Fremont, CA, US
Leading compliance efforts for pre-operative planning (including SaMD and AI/ML based software) and robotic surgical platforms ensuring 100% compliance with FDA QMSR and ISO 13485. Conducted DHF audits and internal audits, identifying and resolving 15+ compliance gaps ahead of external audits.Mentored and trained junior engineers in QA best practices, accelerating productivity.Played key role in post-market surveillance, leveraging risk based justification and RCA to resolve 8 high-priority product complaints.Coordinated EMC, biocompatibility, sterilization and shelf-life testing for Class II special controls, supporting multiple successful FDA 510(k) clearances under 21 CFR 88•••60.Brainstormed the integration of design for reliability (DfR) principles into product development, extending robustness for a robotic product line.Collaborated with R&D to implement risk management strategies (ISO 14971 and IEC 62304) and Cybersecurity SPDF across 5 product lines, improving risk controls, deriving Benefit to Risk ratio and vulnerability management.Supported reviewing the Bio burden testing strategy for EO sterilization of the robotic platformParticipated in the use risk assessments per ISO 62366, identifying and proposing risk controls for 10+ use risks with no residual risks.Spearheaded the process validation of critical IQC processes, reducing non-conformances by 35%.Standardized product inspection criteria GD & T and gage R&R methods for critical dimensions, increasing reliability and reducing rework by 20%.Streamlined the nonconformance and CAPA processes by optimizing trending and RCA investigations.Overhauled QMS with updates of over 40 SOPs and work instructions to align with regulations.Directed supplier qualification and corrective action efforts, resulting in a 50% reduction in incoming material defects over a 12-month period.Provided extensive backroom management support resulting in a successful FDA inspection with zero findings.
EDUCATION
Little Angels Modern High School
High School
Birla Institute of Technology and Science, Pilani
Master of Science (MS), Software Systems
Università degli Studi di Perugia
Master of Business Administration (MBA), Quality, Lean and Knowledge Management
Calbright College
Cybersecurity
University of Bradford School of Management
Master of Business Administration (MBA), Sustainability, Strategic Management
St. Joseph's Pre-University College
Physics, Chemistry, Mathematics and Computer Science
Annamalai University
Bachelor's Degree, Electrical and Electronics Engineering
TIAS School for Business and Society
Master of Business Administration (MBA), Innovation Management
SKILLS
ABOUT KAILASH KALIDOSS
I help transform lives by ensuring medical devices are safe, effective, and reliable. Maximizing innovation while mimimizing \"Cost of Poor Quality\".Are you looking for an engineering management professional who is enthusiastic about collaborating with the design of critical systems in highly controlled industries? My brand of work would be a great fit!With 15+ years of experience consulting for complex MedTech projects from ideation to product launch, I bring a bold and out-of-the-box perspective to the industry. As an AAMI certified QA/RA, I\'m a good strategist when it comes to bridging engineering and compliance without stifiling innovation. Currently, I work for a cutting-edge hard tissue robotic surgical firm based in the Bay area of California, where I\'m constantly pushing boundaries through risk–benefit balancing. As a result, I help transform lives which may otherwise be more difficult, more painful and perhaps, shorter. Please refer to the experiences section for indepth insights. An aerospace enthusiast with a NASA badge to boot an ASCAN courtesy Titans that\'s not all - I\'m also a passionate aerospace enthusiast and a student pilot. Thanks to my love of all things Aerospace, I was recognized as a Solar System Ambassador by NASA in 2020 and as an astrounaut candidate by Titans Space in 2025 - a true honor that reflects my other passion. I strive to integrate my passion for aerospace with my MedTech expertise and make a difference to the community. Ranked Captain in the Civil Air Patrol, a United States Airforce Auxiliary, I\'m able to make award winning contributions to Aerospace Education and Safety while being part of the aircrew. Always learning, always relevant My academic career is well-rounded, with an MBA from a prestigious B-School, and MS and Engineering bachelor’s degrees that complement my professional experiences and a professional Leadership and Communications Certification from Harvard among several others. When I\'m not working, you can find me spending time with family, traveling, continuously learning new trades, and playing an occasional game of Cricket and Chess. 🤝 Ready to make a real difference? Let\'s team up and change the world! If you\'re looking for someone who is futuristic, fully invested, and a forever student of MedTech and Aerospace, I\'m your go-to person. I\'m determined to make a difference in the industry and beyond. Let\'s connect and make a positive impact together!
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