Sneha Singh

• Ensured compliance with quality standards and customer requirements as a Quality Engineer at DMAX, General Motors. • Conducted root cause analysis and implemented corrective actions to effectively resolve quality issues. • Applied quality tools and data analysis to drive defect reduction and enhance process improvement. • Collaborated with cross-functional teams to promote manufacturing excellence and continuous improvement initiatives.

At ALTEN Technology, I interpreted product development goals and FDA regulations (21 CFR Part 820, ISO 13485) to define quality expectations for medical devices, ensuring early alignment between design inputs, risk controls, and inspection protocols during cross-functional kickoff meetings. I collaborated with manufacturing and engineering teams to develop control plans and PFMEA documentation using Minitab and Excel, integrating key characteristics (KCs) and critical-to-inspection (CTI) features into test protocols and operator instructions. I executed incoming and in-process quality inspections for mechanical assemblies using gage R&R, visual standards, and precision tools such as calipers and micrometers, enabling the detection and isolation of dimensional non-conformances that reduced batch rejections by 18% over two quarters. In addition, I logged nonconformance reports (NCRs) in TrackWise and eQMS, conducted defect trend analyses, and facilitated structured root cause investigations (Fishbone, 5 Whys) as part of Material Review Board (MRB) activities. Partnering with sustaining engineering, I developed and tracked corrective and preventive actions (CAPA) tied to field failures and audit findings, using weekly quality metrics dashboards to monitor effectiveness. I also generated inspection summary reports and risk control documentation for Design History Files (DHF) and Manufacturing History Records (MHR), ensuring alignment with FDA QSR and ISO 14971 standards, and presented findings during biweekly stakeholder reviews. Through continuous improvement initiatives, I launched feedback loops between operators and quality inspectors, documented lessons learned, and updated control plans—resulting in a 22% improvement in first-pass yield across two product lines within three months.

At Larsen & Toubro, I partnered with cross-functional engineering teams to review project requirements, customer specifications, and regulatory standards (ISO 9001, ASTM, API), translating quality goals into actionable inspection criteria and aligning early-stage deliverables. I developed and executed comprehensive inspection and test plans (ITPs) for precast structures and piping systems using MS Project, AutoCAD, and SAP QM, ensuring milestone-based quality checkpoints were integrated into the construction lifecycle. I conducted in-process and final quality audits on structural components and vendor-supplied materials using Non-Destructive Testing (NDT), ultrasonic testing, and visual inspections, achieving a 27% reduction in rework over two quarters. Additionally, I logged and categorized non-conformities and deviations using JIRA and Smartsheet, then led root cause analysis sessions (5 Whys, Fishbone diagrams) to identify systemic gaps and recommend corrective actions. Collaborating with procurement, vendor QA teams, and on-site engineers, I resolved high-priority quality issues and ensured supplier compliance through quality rating dashboards, follow-up audits, and updated acceptance criteria. I also delivered weekly and milestone-based quality performance reports to stakeholders using Power BI and Excel, highlighting trends, risks, and key metrics such as defect density, inspection pass rate, and vendor performance scores. By implementing post-closure follow-up mechanisms within continuous improvement frameworks (PDCA, Kaizen), I drove a 15% year-over-year improvement in first-pass yield and institutionalized preventive practices across ongoing projects.