Jalpana Patel
Algonquin,IL
Summary
Dedicated Quality Engineer with a strong background in quality assurance and Microsoft Office proficiency, complemented by a Bachelor's in Commerce from H.K. Commerce College, University of Gujarat. Actively pursuing ASQ certification. Known for excellent organizational and leadership skills, with expertise in multitasking and effective decision-making. Skilled in problem-solving and team collaboration, with a solid understanding of regulatory compliance and data analysis. Committed to continuous improvement and quality excellence in dynamic environments.
Overview
16
16
years of professional experience
Work History
Quality Engineer
Young Innovations
09.2017 - Current
- Conducted comprehensive quality inspections across various stages (incoming, in-process, final) and processes (repackaging, relabeling, kitting) to ensure adherence to industry standards.
- Investigated and resolved customer complaints for a diverse product range including Obtura, Plak Smacker, Ortho Store, Ortho Specialties, and My Dent, enhancing customer satisfaction.
- Played a key role in the enhancement of Quality Processes through innovative ideas and regular updates to Quality procedures and work instructions.
- Ensured compliance with regulatory standards by approving Certifications of Compliance and managing production issues promptly.
- Developed and implemented Corrective and Preventive Actions (CAPA) and Device Change Records (DCR) as needed, addressing potential quality issues proactively.
- Maintained Device History Records (DHR) in accordance with FDA requirements, ensuring accurate and comprehensive documentation.
Gage Calibration Technician
AMTEC Precision and Production
11.2016 - 09.2017
- Managed monthly in-house and external gauge calibrations, maintaining over 7,000 gauges to ensure accuracy and compliance.
- Handled gauge setup, ordering, resetting, and minor repairs, along with proficiency in various gauge calibrations including tracing and roundness testers.
- Oversaw procurement processes, including purchase requests, vendor quotes, and receipt handling, and prepared gauges for new product development.
Quality Control Inspector/Back up Supervisor
Richard Wolf Medical Instrument Corporation
05.2016 - 10.2016
- Managed in-process and final inspections across multiple departments, including sterilization products, and maintained quality inspection data; skilled in SAP navigation and NCMR processes.
- Proficient in calibrating, using, and repairing various gauges (like Micrometers, Calipers, and Dial Gauges), with knowledge in blueprint reading and Millipore testing.
Quality Lead
Covidien
05.2008 - 05.2016
- Oversaw health and safety compliance, product quality standards, and FDA/OSHA regulations in a manufacturing environment, including inspections for Sharps Containers and Syringes.
- Demonstrated proficiency in using various gauges, GD&T, and blueprint reading, coupled with experience in visual, dimensional, and functional testing in clean manufacturing settings.
- Managed the release of finished products and environmental monitoring, efficiently handling systems like BPCS LX and LIMS, and overseeing quality control processes for incoming products.
- Led a team of 8 QC inspectors, ensuring product compliance with customer requirements and AQL standards, and actively contributed to validation activities and quality audits.
Education
Bachelor of Arts - Advance Accounting and Auditing
Gujarat University
04.1996
Skills
- Six Sigma Green Belt
- Internal Audit Certification
- Proficiency in Microsoft Office
- Team Collaboration and Leadership
- Effective Multitasking
- Strong Communication Skills
- Complex Problem Solving
- MiniTab Statistical Analysis
- Data Analysis Certification
- Knowledge of FDA, BSI, and Internal Audits
- Trained in Root Cause Analysis
Timeline
Quality Engineer
Young Innovations
09.2017 - Current
Gage Calibration Technician
AMTEC Precision and Production
11.2016 - 09.2017
Quality Control Inspector/Back up Supervisor
Richard Wolf Medical Instrument Corporation
05.2016 - 10.2016
Quality Lead
Covidien
05.2008 - 05.2016
Bachelor of Arts - Advance Accounting and Auditing
Gujarat University
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