SKILLS

Sweta Ashara

***** ******* ***** ****** ****** TX 78727 317-***-****

ad434g@r.postjobfree.com· linkedin.com/in/sweta-ashara/

Excellent analytical, problem-solving, communication, leadership, management, decision-making skills.

MATLAB, DAX, Data Visualization, SQL, Power BI, Power Automate, Power Apps, Data modeling, Minitab, Tableau.

ISO 13485, 21 CFR 820, AS9100, AIAG, Corrective and Preventive Action (CAPA), Verification and Validation(V&V), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Data Analysis, Statistical analysis, Design Control, Engineering Design, Risk Management, Failure Mode and Effect Analysis (FMEA), Basic Maintenance, Servicing, and Installation, GD&T Basics, APQP, PPAP, Gage R&R.

EXPERIENCE

QA Engineer, Tesla Inc, Austin, TX Nov 2023-April 2024

Performed CAPA Audits to ensure compliance with company’s policies and 8D procedures.

Provided strategic solution for identifying Top Quality Issues considering issues related to manufacturing lines, number of contained parts, return rate, cost of poor quality and yield loss.

Created detailed PFD for various manufacturing lines pertaining to cell manufacturing.

Created and deployed software system for requesting and executing containments. Quality Manufacturing Engineer, Zeda Inc, Cincinnati, OH Sept 2022-Nov 2023

Designed and improved manufacturing processes using lean techniques, optimizing efficiency, reducing waste, and improving product quality while adhering to customer requirements and industry standards.

Developed and maintained process documentation, such as manufacturing process flow, bills of materials, work instructions, control plans, and inspection reports.

Analyzed production data and utilized quality tools such as process capability analysis, Failure Mode and Effect Analysis (FMEA), and statistical process control (SPC) to analyze and improve process performance, minimize defects, and boost customer satisfaction.

Developed and implemented inspection and testing plans for all in-process and finished goods.

Collaborated closely with customers, vendors, and internal cross-functional teams, ensuring manufacturability and customer satisfaction.

Developed validation protocols (IQ/OQ/PQ) and validation procedures for Additive Manufacturing and CNC machining Equipment.

Conducted root cause analysis, corrective and preventive action (CAPA) investigations to identify and eliminate sources of nonconformance (NCR).

Conducted meticulous Gage R&R studies to assess measurement system variability and ensure precision in manufacturing processes.

Conducted and led internal and external audits to ensure compliance with regulatory standards and customer requirements, prepared audit/summary reports, and collaborated with the team on mitigation actions. Quality Assurance Engineer, Lantz Medical, Zionsville, IN Aug 2020- Sept 2022

Created comprehensive retrospective DHF, DMR, and DHR documentation. Performed design and software validation and verification (V&V), authorizing precise testing protocols and test methods.

Optimized and implemented quality procedures, conducted, and supported internal audits, created automated workflows, and improved various processes in the manufacturing facility.

Investigated customer complaints and implemented an effective CAPA and non-conformance identification system.

Served as a project/quality manager in new product development, ensuring compliance with design controls requirements by identifying project requirements, developing plans, managing, and communicating with vendors, allocating resources, reviewing milestones, creating, and executing product validation plans and design control documentation for successful product launch.

Developed multiple software application systems for company processes such as complaints, maintenance, shipping, and receiving, revolutionizing data collection, and enabling data modeling, analysis, and visualization, to further open any corrective or preventive action to improve processes, reduce waste and increase efficiency.

Designed queries and dashboards for management review, providing valuable insights, relationships, and growth recommendations.

Collaborated seamlessly with diverse departments to optimize workflows and enhance internal system integration.

Designed and deployed multiple applications system software for warehouse inventory management, including material inventory. EDUCATION

Purdue University, Indianapolis May 2020

Master of Science (MS), Biomedical Engineering, 3.4 GPA Mumbai University, Mumbai, India May 2017

Bachelor of Science (BS), Biomedical Engineering, 4.0 GPA Lean Six Sigma Black Belt July 2022

ISO 13485 Lead Auditor Training Nov 2022