Meet Patel
Status :,US Citizen
Summary
Quality Engineer with over 3 years of experience in Medical manufacturing Industry, Management and Control of the Supply Chain demonstrated leadership abilities in collaborating with other departments to produce high-quality products in order to maintain continuous improvement and, as a result, surpass benchmarks.
Overview
4
4
years of professional experience
Work History
Quality Engineer
Abbot Laboratories
Gurnee, IL
09.2022 - Current
- Focusing on a manufacturing of an BinaxNow Covid -19 rapid tests.
- Review IQ, OQ, PQ data.
- Duties involve using different procedures, requiring the use of judgment and analysis of facts to determine action to be taken within the limits of established acceptance standards.
- Essential Duties and Position Responsibilities: Performs independent review materials for conformance to specifications, Excel spreadsheets. Ensures that all product lots meet the established in-process procedures, specifications and inspections, before his/her approval to release.
- Maintain DHR records, procedures, and specifications. Review lot history folders for final lot release sign off and files them in the appropriate location. writing inspection and test procedures and other documents relevant to incoming/receiving inspection, work in process, finished product and Lot Release.
- Audits, CAPA and preparation of the Management Review deck.
- Review yield data and aide in reducing scrap.
- Conducts research for failure investigations pertaining to floor defects, field returns and customer returns in order to determine root cause.
- Lead the investigation, resolution and prevention of product and process non-conformances.
- Identify and implement effective process control methods to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
- Follow established company rules and regulations, safety precautions, and maintain quality standards.
- Review incoming between the company's senior management team and vendors to identify issue and come up with solution.
- Manage supplier performance by conducting regular audits, quality meetings, and tracking improvement activities.
- provide performance feedback to suppliers based on quarterly.
Quality And Manufacturing Engineer
Flex International
Buffalo Grove, IL
08.2019 - 09.2022
- Performed bench testing, analysis and evaluations of high reliability Class I ,II, III Medical products.
- Visual Inspection of Medical Device and Manually by lab testing.
- software Mess pro to corrections and remove data for Quality Label and production label.
- Using EDHR to do Dailey basis Quality inspection reports and change lot or start up for new processor number.
- Improved customer value using 5S and Lean Manufacturing principles.
- Maintain Non-Conforming log configured NCMR report.
- Monitored clean room operations to ensure compliance with FDA and GMP requirement.
- Ensure good manufacturing practices are in place and are being followed.
- Create, maintain, and modify excel spreadsheets to provide records.
- Verify packaging, marking, and recording of finished goods is correct and complete.
- Communicate all re-work and transfer issues with management.
- Inform QA Manger, supervisor or any other member of management of any product safety or quality issues or of any processes which become noncompliant with specifies requirements.
- Prepare and record all customer and third-party samples in a timely manner.
- Create and maintain all required document for Internal and External audits.
- Monitoring of the hygienic condition of lab and plant participant in GMP Management.
- Have quality expertise and is qualified to make such changes and/or set-up a machine/manufacturing process at floor management direction.
- To guarantee a clean and secure work atmosphere, a defined safety protocol has been followed by me and was continuously monitored.
- Complied with all safety protocols and complied with the QA Manager orders to regularly meet production quotas
- Review incoming between the company's senior management team and vendors to identify issue and come up with solution.
- Manage supplier performance by conducting regular audits,quality meeting's, and tracking improvement activities.
- provide performance feedback to suppliers.
Education
Bachelor of Science - Mechanical Engineering
Sarvepalli Radhakrishnan University
Bhopal , India06.2019
Skills
- Root Cause/Corrective Action Preventative Action
- Lean Manufacturing
- Manufacturing/Production/5S
- GMP&GDP
- Agile Methodology
- Risk Management
- New Product Development
- Time Management
- Six Sigma Methodologies
- Process Control Documentation
- Root Cause Analysis
- Team Leadership
- Continuous Improvements
- Multitasking and Organization
- Non-Conforming Material Reports
- Inspection Processes
- Document Quality
- CRM Software,
- Waste Reduction
- Material Review
- PPAP Submissions
Accomplishments
Received an Spot award for being a key technical member contributor on the Scrap Reduction Team as I provided co-leadership on a team which directed product evaluations and redefined workmanship criteria which led to an immediate scrap cost avoidance of approximately $75,000 savings to the company.
Timeline
Quality Engineer
Abbot Laboratories
09.2022 - Current
Quality And Manufacturing Engineer
Flex International
08.2019 - 09.2022
Bachelor of Science - Mechanical Engineering
Sarvepalli Radhakrishnan University
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