Indravadan Patel
Streamwood,IL
Summary
Results-oriented Quality Engineer polished in developing quality improvement plans and monitoring employee performance to cultivate adherence to company standards. Focused and driven with aptitude for process improvement. Dedicated to going above and beyond to mitigate risk and improve quality. Effective quality professional bringing proven success in driving continuous improvement initiatives in Quality Engineer roles. Focused and diligent with commitment to fostering corporate mission. Consistently acknowledged for implementing actionable initiative to reduce error rates and optimize company processes. Thorough Quality Engineer adept at performing quality inspections and identifying root causes for non-conforming material issues. Hardworking and meticulous with a passion for continuous improvement.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Quality Engineer
Abbott Medical Devices
Gurnee, IL .
09.2022 - Current
- Experienced with Batch record, quality incident reporting and daily record update and activates of material review Board(MRB).also review of non conformance material(NCMR).worked and supported in team with Material Review Board(MRB) and non -conforming report activity in QA and QC department
- Also solve problem with supplier material in incoming quality department and production NCR MRB activates(Internal and external for material on hold due to NCR and QI ).work directly with QI owner, NCMR Owners and resolved NCR TO CLOSURE
- Experienced and worked with planning, production, operations, engineering, product engineering for MRB activates. also experiences working with supplier Quality, quality Engineering, quality control and maintained up to date status and disposition plans for all materials on hold. communicated with material supplier customers on every day for updates on all NCMR's and MRB Material and disposition plan with QC staff, Material Handlers, warehouse employees and liaison to various functions with different department in organization.
- Supported quality team members during corrective action updates
- Contributed to root cause analysis to determine core reason for failures and errors
- Reported on non-compliance issues and other negative factors discovered during production
- Coordinated with quality control staff to complete inspections
- Performed quality inspections and drafted reports to detail non-conforming material issues
- Maintained compliance with industry standards and regulatory compliance during managed projects.
- Reported on non-compliance issues and other negative factors discovered during production.
- Developed and implemented comprehensive quality assurance program to guarantee organization products met safety and quality standards.
- Developed action plan for company certification using ISO 9000 standard knowledge.
- Facilitated process improvements to successfully decrease errors.
- Developed traceability documentation to aid in investigating faults and defects.
Quality Engineer
Flexan
Lincoln, IL
06.2022 - 08.2022
- Contributed to root cause analysis to determine core reason for failures and errors.
- Supported quality team members during corrective action updates.
- Performed quality inspections and drafted reports to detail non-conforming material issues.
- Coordinated with quality control staff to complete inspections.
- Led problem-solving activities to quickly identify and permanently resolve quality and productivity issues.
- Maintained compliance with industry standards and regulatory compliance during managed projects.
- Partnered with senior management to analyze issues and find appropriate solutions.
- Researched and evaluated new techniques and technologies to improve product quality.
- Developed and implemented comprehensive quality assurance program to guarantee organization products met safety and quality standards.
- Facilitated process improvements to successfully decrease errors.
- Executed operational audits and assessed company operations, compliance and other associated risks.
- Reported on non-compliance issues and other negative factors discovered during production.
- Escalated concerns about project and process quality, referring discovered issues to engineering manager for correction.
- Developed traceability documentation to aid in investigating faults and defects.
- Developed action plan for company certification using ISO 9000 standard knowledge.
- Recommended revisions to internal controls and operational and management policies and procedures.
- Conducted technical evaluations of engineering designs and test results.
Quality Engineer
Argon Medical Devices
Wheeling, United States
10.2014 - 06.2022
- Coordinate all activates pertaining to ISO 9001 and ISO 13485 quality management system and FDA21 CFR820 quality systems regulation, including continuous improvement and quality assurance
- Monitor non-conforming material in the plant and prepared weekly reports on the status of rework inventory, ERP updates, and documentation
- Performed process and product, and system audits, communicating quality issues with employees and management
- Coordinated process troubleshooting efforts with engineering
- Completed activities related to customer complaint process and CAPA investigation and follow-up
- Performed internal audits for ISO-9001 and ISO 13485 QMS also issued CAPA timely closer
- Maintained training records in ERP including job description actively
- Experienced and used measuring tools like DGT AND CMMR, root cause analysis, corrective action, and poke yoke
- CAD ,design and GDT, tolerance stack analysis, tool room environment and CMM principles. Box G
- P validation Accelerated validation with regular testing (software secured validation used to check contamination of material using software secured validation
- Irons graph and material hardening tester.)
- Resolved problems by analyzing data, investigating issue, identifying solutions, and recommending actions
- Coordinated and interacted with head and department lead to understand process and documentation
- Utilized gage calibration systems repair or replaced gages as needed
- Prepared PPA (production parts approval process for new products as needed
- Monitored supplier performance and conduct supplier audits and maintained training records
- Supported quality systems process to maintain quality system compliance and effectiveness throughout the value stream from supplier through design/manufacturing and to the customer
- Experienced with lead quality systems process including MRB/DMR, RMA, CAPA, and internal audit and collaborated with members of the AQR team members of company
- Strong computing experiences with ERP, customer, supplier, and regulatory portals.
- Coordinated with quality control staff to complete inspections
- Performed quality control audits on pre-production supply chain, verifying continuity of raw materials.
- Reviewed and validated quality requirements for manufacturing planning, supplier purchase orders, and engineering specifications to meet contract compliance regulations.
- Supported quality team members during corrective action updates.
- Coordinated with quality control staff to complete inspections.
- Contributed to root cause analysis to determine core reason for failures and errors.
- Performed quality inspections and drafted reports to detail non-conforming material issues.
- Adhered to federal guidelines for quality control inspection.
Education
Bachelor of Science - Electrical Engineering
Maharaja Sayajirao University of Baroda
Baroda,India12.1988
Diploma - Industrial Electronics
M.S.University of Baroda
Barorda,India12.1987
Skills
- ISO 9001 standards
- Materials review
- Quality Improvement Plans
- Process Change Documentation
- Non-Conforming Material Reports
- Job Requirement Analysis
- Root Cause Analysis
- Internal Auditing
- Risk Management
Certification
Sun Certified System Administrator (SOLARIS-10)
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote
There is a powerful driving force inside every human being that, once unleashed, can make any vision, dream, or desire a reality.
Tony Robbins
Timeline
Quality Engineer
Abbott Medical Devices
09.2022 - Current
Quality Engineer
Flexan
06.2022 - 08.2022
Quality Engineer
Argon Medical Devices
10.2014 - 06.2022
Bachelor of Science - Electrical Engineering
Maharaja Sayajirao University of Baroda
Diploma - Industrial Electronics
M.S.University of Baroda
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