Kulbir Gill
Sr. Quality Assurance Engineering
- Role
- New Product Manager- Principle Quality Engineer at Actalent
- Location
- Fremont, CA, US
- LinkedIn followers
- 500 followers
About Kulbir Gill
Kulbir Gill105 Cedar St. Fremont, Ca 9••••••••@comcast.net. Cell: 51••••••48Summary: Objective: Seeking a Sr. Principal Engineer position in a Medical Device Company. A Core leader of the cross-functional team (R&D, QA/RA, Operation, Project Management, & Manufacturing) to resolve critical business-impacting issues.Medical Devices & Implantable,Robotic System, Implantable, Combo Implantable & Drug, endoscopy, Spine, Orthopedics, Ultrasonic, LVAD, Catheters, HIV genotyping GeneChip, Diabetic Pump, Balloons, ENT, Surgical Instruments, Coblation, Suture Implants…Summary: A result-oriented highly technical engineering/manager with class & II experience. With extensive knowledge of Medical devices, Quality systems, design assurance, ISO-13485, ISO-14971, IEC 62304, & FDA requirements.Area of Expertise Includes Quality Systems, Design Control, Leading teams, Product development, Product Qualification, Validation, IQC, and Supplier Management. Standards: Regulation 21 CFR part 820, ISO 13485 and 9001, ISO 14971(Risk Management), MDD, ASTM, ANZI, & ASQ.Software: Advance knowledge of QP3, IEC 62304 Software Validation, & Software Verification, Minitab, TECHs, Agile, JDE, SAP, Oracle, MS Project, MS Office, Solidworks, Word. Excel, Visio, PowerPoint 2013, Trackwise. Specialties: Training: ISO 13485, FDA 820, ISO 14971, Six Sigma-Green Belt, “Project Management”, “Foundation of Leadership”, “Dare to Lead”, “Effective Teamwork Strategies”, “High Performance Teams”,” Effective Communication” & CQE. Education: Mechanical Engineering BS, 4 Years, England. Minor: CSE
Experience
New Product Manager- Principle Quality Engineer
Aug 2023 — Present · San Francisco, CA, US
New Product Development: Managing three new diagnostic products.• Leader of Design Control through out the world organization. • Leading Risk Management: ISO-14971• CORE Member of Sterilization Team• CORE Member of Bio-Compatibility• CORE Member of Human Factor Engineering Team• CORE Member of Clinical Evaluation Team• CORE Member of Packaging Validation Team• Quality Management System SME.
Education
Engineering
BSME, Mechanical Engineering
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