Ankit Harsora
Global Commercial Quality ┃ ASQ CMQ/OE ┃ ASQ CQE ┃ CSSGB
- Role
- Team Lead - Cps Quality Engineering at Ascensia Diabetes Care
- Location
- Woodbridge, NJ, US
- LinkedIn followers
- 500 followers
About Ankit Harsora
I am a Quality leader with 10+ years of experience driving strategy, compliance, and continuous improvement across the medical device lifecycle. My expertise spans R&D design transfer, manufacturing, commercialization, and post-market surveillance, with a proven track record of delivering measurable impact through Lean Six Sigma, AI, and data analytics.I have successfully led cross-functional teams to reduce product failures, streamline processes, and implement digital quality solutions that improve efficiency, compliance, and customer experience. With 6+ years of people management experience and certifications including ASQ CMQ/OE, ASQ CQE, and Lean Six Sigma Green Belt, I am passionate about building high-performing teams and advancing innovative quality strategies that improve patient outcomes.
Experience
Team Lead - Cps Quality Engineering
Jun 2023 — Present · Parsippany, NJ, US
Global Commercial Quality
Education
University of Southern California
Master of Science (M.S.), Medical Device & Diagnostic Engineering (Quality Systems & Regulatory Affairs)
2013 — 2015
Skills
- Nda
- Scar
- Proteus
- Technical Writing
- Research
- Fmea
- Quality Assurance
- Ide
- Quality Control
- Dhr
- Public Speaking
- Statistical Process Control
- Java
- Iso 13485
- Presentation Skills
- Matlab
- Medical Devices
- Capa
- C
- Microsoft Office
- Patent Applications
- Biomedical Engineering
- Dmr
- C++
- Quality Auditing
- Pmas
- Teamwork
- Fda Gmp
- Risk Management
- Communication
- Statistics
- 21 Cfr
- Microsoft Project
- Ind
- Autocad
- Skilled Multi-Tasker
- Corrective and Preventive Action (Capa)
- Iso 14971
- Design Control
- Powerpoint
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