Ankit Joshi

Co-Founder

Austin, Texas, United States5 yrs 1 mo experience

Key Highlights

Proven track record in reducing operational risks.
Expertise in root cause analysis and risk management.
Six Sigma Green Belt certified professional.

Stackforce AI infers this person is a Quality Engineering professional with expertise in Manufacturing and Pharmaceuticals.

Contact

Skills

Core Skills

Quality EngineeringContinuous ImprovementRisk ManagementValidationManufacturingQuality Control

Other Skills

AutomationAutomotive EngineeringCAECAPAChange ControlCommunicationComplaint InvestigationsComputer Numerical Control (CNC)Computer-Aided Design (CAD)Corporate FinanceCorrective ActionsCorrective and Preventive Action (CAPA)Data IntegrityDocument ReviewDocumentation

About

Quality Engineering professional with 5+ years of experience in manufacturing. Six Sigma Green Belt certified, with expertise in root cause analysis (8D, 5-Why, Fishbone), FMEA, CAPA resolution, and risk management. Proven track record of reducing operational risks, improving product reliability, and ensuring compliance with ISO and federal regulations. Skilled in cross-functional collaboration, supplier management, and continuous improvement initiatives.

Experience

5 yrs 1 mo

Total Experience

2 yrs 6 mos

Average Tenure

2 yrs 8 mos

Current Experience

Flex

Quality Engineer

Oct 2023 – Present · 2 yrs 8 mos · Austin, Texas, United States · On-site

Assisting the SMT team as a quality representative to resolve real-time production, documentation, yield, and compliance-related issues.
Resolved real-time production and compliance issues, improving yield and reducing downtime.
Led cross-functional initiatives to optimize procedures, cutting turnaround time.
Initiated and Co-led 5S implementation, enhancing floor safety and efficiency.
Developed quality systems for material disposition, ensuring traceability and compliance.
Collaborated globally to deploy a documentation tool, standardizing quality event tracking.
Supported investigations and CAPA resolution for nonconformances and deviations.
Provided technical support in failure mode analysis and risk evaluation.

Continuous ImprovementLean Six SigmaRoot Cause AnalysisCAPARisk ManagementSupplier Management+1

Bd

Senior Quality Engineer

Sep 2022 – Oct 2023 · 1 yr 1 mo · Massachusetts, United States · On-site

Led NPI efforts, ensuring smooth transition from design to production.
Implemented scalable manufacturing processes, improving early-stage yield.
Conducted pFMEA and dFMEA activities for robust risk management.
Reviewed CAPAs, nonconforming materials, and supplier corrective actions via MasterControl.
Conducted supplier audits to identify and mitigate pre-production risks.
Approved production batches and monitored quality metrics for compliance.
Applied root cause analysis tools to resolve nonconformances in line with GxP standards.

NPIpFMEAdFMEACAPASupplier AuditsRoot Cause Analysis+2

Pfizer

Quality Validation Engineer

Jun 2021 – Aug 2022 · 1 yr 2 mos · Kalamazoo, Michigan, United States · On-site

Supported validation of COVID vaccine formulation and filler control room equipment.
Developed and executed validation plans, vendor assessments, and commissioning protocols.
Optimized cleaning cycles for CIP/COP equipment, improving energy efficiency.
Led risk assessments for system impact, data integrity, and component criticality.
Mentored junior engineers in validation methodologies and best practices.
Conducted root cause analysis on deviations during validation activities.

Validation PlansRisk AssessmentsRoot Cause AnalysisData IntegrityQuality EngineeringValidation

Gearfoot motors

Co-Founder

Jun 2018 – Jul 2019 · 1 yr 1 mo · Delhi

Oversaw the manufacturing and quality inspection of FDM 3-D printers
Supervised a team for research and development of an electric motorcycle and charging plant.
Designed and fabricated custom parts for collegiate and professional projects.
Prepared and conducted annual extra-curriculum syllabi for STEM Ed activities in
collaboration with colleges and schools relating to 3-D printing and additive manufacturing.
Prepared and conducted Workshop syllabi for colleges based on Machine Learning &
Automobile Engineering.

ManufacturingQuality InspectionResearch and DevelopmentQuality Engineering

Novartis

Quality Engineer

Feb 2017 – Jul 2019 · 2 yrs 5 mos · India · On-site

Created inspection plans based on design specs to verify critical dimensions.
Improved product reliability through regression testing and quality assurance.
Facilitated communication between QA, development, and project teams.
Supported supplier PFMEA and internal PRM compliance with ISO 14971.
Managed QMS responsibilities including CAPA, complaint handling, and document control.
Enhanced customer satisfaction through timely resolution of nonconformances.

Inspection PlansQuality AssuranceSupplier ManagementQuality EngineeringQuality Control