Shulamite Sahoo
Fremont,CA
Summary
More than 10 years of experience in the Quality Assurance and R&D fields. Extensive background in Quality Assurance and R&D with supervisory experience. Excellent at independently establishing cross-functional team communication, managing product development life cycles including validation and launch; analyzing manufacturing process controls; project management; and training and implementation. Very capable liaison between technical and non-technical teams, creating understanding between groups. Committed to leveraging a lean approach and technical presentations to drive manufacturing readiness and cost reductions.
Overview
11
11
years of professional experience
Work History
Sr Quality Engineer
Intuitive
Sunnyvale, CA
06.2021 - Current
- Led Quality Engineering efforts for MP Vision and Endoscopes group, effectively working with Manufacturing Engineering group with product quality concerns
- Conducted root cause analysis to identify and foster process improvements, mitigate risk, monitor incoming material, and address production and final quality inspection issues.
- Generated engineering documentation and oversaw design projects.
- Investigated customer returns and complaints utilizing problem solving techniques such as 8D or 5 Why Analysis.
- Supported development of new products through verification of adherence to applicable industry standards.
- Mentored junior engineers on quality standards and best practices.
- Facilitated internal audits to assess adherence to quality processes.
- Evaluated and sanctioned design modifications to ensure compliance with regulations.
Senior QA Engineer
Sight Sciences, Inc.
Menlo Park, CA
04.2019 - 06.2021
- Led team in executing manual and automated testing processes.
- Analyzed requirements and specifications to ensure thorough test coverage.
- Documented test results and generated reports outlining product quality metrics.
- Performed exploratory testing to uncover potential issues with new features or products.
- Conducted regular quality audits and assessments to ensure adherence to quality management systems.
- Managed supplier quality performance, ensuring materials met stringent quality requirements.
Senior Supplier Quality Engineer
Johnson & Johnson Vision, formerly Abbott Medical Optics (AMO)
Milpitas, CA
10.2015 - 04.2021
- Implemented proactive measures to enhance product quality
- Eager to learn and apply new skills, consistently meeting project deadlines
- Streamlined Quality Engineering processes, enhancing cross-departmental product excellence
- Worked closely with VPs and Directors across various departments
- Fostered team synergy to meet critical project milestones efficiently
- Refined testing protocols to detect subtle defects, significantly reducing rework
- Partnered effectively with Manufacturing to address and resolve quality issues
- Conducted independent audits and design reviews, ensuring product compliance
- Excelled in mold tool design verifications and validations
- Evaluated new product design and quality through comprehensive manufacturing process instructions and test plans
- Enhanced QA protocols, reducing error rates by 20% through strategic audits
- Qualified and assessed component and process in LASIK, cataract diagnostic and surgical suites
- Provided technical support for quality and manufacturability improvement
- Validated inspection methods for Incoming Inspection Quality Assurance
Quality Engineer, Quality Assurance and Quality Operations
Alcon Laboratories
Johns Creek, GA
06.2014 - 09.2015
- Spearheaded process improvement projects for increased visibility and reduced redundancy
- Implemented Lean Six Sigma, leading to $25,000 annual cost reductions
- Managed Quality Operations, Records Review, and Lens Inspection teams
- Directed non-conformance incidence input and approval using TrackWise
- Designed CAPA plans for recurring issues, overseeing document control changes
Education
Master of Arts - Teaching
Earlham College
Richmond, IN07.2011
Bachelor of Science - Polymer And Fiber Engineering
Georgia Institute of Technology
Atlanta, GA05.2007
Skills
- Quality Assurance and Quality Systems
- Project management
- Lean Approach
- Quality System Audits
- Corrective and Preventive action (CAPA)
- Manufacturing Readiness
- Risk Management
- Lean Six Sigma
- Operational Excellence
- New Product Development
- Regulatory Compliance
Languages
- English, Expert
- Mandarin Chinese, Skillful
Activities
- Making A Difference (MAD) Award, 06/01/21, 2022, 2023, 2024
- Johnson & Johnson Vision Encore Award, Bronze: MDSAP Audit Team, 2018
- Supplier Quality Engineering North America Representative, Johnson & Johnson Credo Team, 2018-2019
- Abbott Laboratories Excellence Bronze Award for Abbott Values, 2016
- Member, United States Masters Swimming, 09/01/02 - Present
- Member, Bay Area Disc Association, 2023 - Present
Accomplishments
- Making A Difference (MAD) Award Recipient of numerous awards for demonstrating extra effort, unique contributions, and major achievements. Jun 2021, 2022, 2023, 2024|
- Johnson & Johnson Vision Encore Award, Bronze: MDSAP Audit Team 2018
- Supplier Quality Engineering North America Representative, Johnson & Johnson Credo Team 2018-2019
- Abbott Laboratories Excellence Bronze Award for Abbott Values 2016
- Quality Token Program, Alcon Laboratories, 2014-2015
Affiliations
Member, United States Masters Swimming
Member, Bay Area Disc Association
Founding Member, Richmond Community Orchestra
References
References available upon request.
Timeline
Sr Quality Engineer
Intuitive
06.2021 - Current
Senior QA Engineer
Sight Sciences, Inc.
04.2019 - 06.2021
Senior Supplier Quality Engineer
Johnson & Johnson Vision, formerly Abbott Medical Optics (AMO)
10.2015 - 04.2021
Quality Engineer, Quality Assurance and Quality Operations
Alcon Laboratories
06.2014 - 09.2015
Master of Arts - Teaching
Earlham College
Bachelor of Science - Polymer And Fiber Engineering
Georgia Institute of Technology
Similar Profiles
Carlen Kai Del RosarioCarlen Kai Del Rosario
Systems Support Lead at IntuitiveSystems Support Lead at Intuitive
Brian Rowe - PMPBrian Rowe - PMP
Sr. Technical Implementation Project Manager- Robotic Surgery at IntuitiveSr. Technical Implementation Project Manager- Robotic Surgery at Intuitive
Gabriel SalinasGabriel Salinas
Sr. Production Manager Reposable Instruments at IntuitiveSr. Production Manager Reposable Instruments at Intuitive
Chris LarrewChris Larrew
Senior Product Release Specialist at IntuitiveSenior Product Release Specialist at Intuitive
Jorge Zamudio SanchezJorge Zamudio Sanchez
Technical Program Manager, Wiring Harness Systems at Lucid MotorsTechnical Program Manager, Wiring Harness Systems at Lucid Motors