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Click here or scroll down to respond to this candidate1Candidate's Name
E-Mail: EMAIL AVAILABLEMobile: PHONE NUMBER AVAILABLELocation: Lincolnshire, IL, Street Address
Profile Summary:I have approximately 10 Years of working experience in medical devices industry in different roles working across top leading organizations or customers e.g., Actalent Engineering and Science, Johnson & Johnson, Zimmer Biomet, Instru-Med Inc., Avalign Technologies. Worked in various capacity as Project Manager, Project Lead, Sr. Quality Engineer, Software Testing, etc. Experienced in Quality, Hip, knees, Femoral, R&D, Packaging, Manufacturing, Inventory and calibration departments, Specialist with a demonstrated history of working in the medical device industry / FDA 21 CFR11, 21 CFR820, ISO 9001, ISO 13485, quality regulation, design, and process verification/ validation(IQ/QQ/ PQ), Design Traceability Matrix, new product development, CAPA, Nonconformance, and Years of experience in working within the STEM arena.Having extensive experience in medical device industries products also, PPE products like apparels and gloves. Skilled in Microsoft Word, Sales, Public Speaking, and Management. Strong quality assurance professional with PMP Certification, Six Sigma (Black Belt) and Bachelor of Science (Engg.) graduate in Electronics and Communications. Key Competencies: Experienced in handling successfully several projects as a Project Manager with key functions defining project scope, duration, resources and scheduling, tracking, issue management, risk management, change management, customer specific requirements/Statement of Work(SOW) and status reporting as well as the best course of action/approach to attain the project objectives. Plans and coordinates work with teams. Designs and implements project plans. Experience in delivering successfully NPD (New Product Development) and existing products. Experience and Strong skills in project scheduling utilizing a project scheduling and portfolio management tool such as Smart sheet. A dedicated team player able to provide value in a challenging work environment, and the ability to deal with problems involving a variety of concrete variables in standardized. Excellent experience in providing training to a team on the ERP system and managing team. Worked in DTM (Design Traceability Matrix), V&V (Validation Verification) document, Sampling, validation (CSV-E, IQ, OQ, PQ), NCR (nonconformance Report), quality hold, CAPA, and all the activities that need in the quality and manufacturing area. Experience within a highly regulated environment (e.g., FDA regulated), 21 CFR 820, ISO 13485, ISO 14971, GAMP5, and other related medical device standards and cGxP experience. Demonstrates skill in applying various risk management and risk mitigation tools and practices. 2 Supervise and direct the efforts of the Quality Control Department with hands-on in Quality Management System (QMS) Software records, including production orders by department, complaints, gage R&R, CAPAs and NCMRs (nonconformance material reports) opened/closed, and quality metrics of orders shipped. Dedicated team player and have given added values in a challenging work environment, and the ability to deal with a complex problem involving a variety of concrete variables in standardized. Certification: Project Management Professional (PMP) Certification Fundamental of Agile & Waterfall Project Management- PMI (Kickoff Waterfall & Agile Badge) Project Management Essentials Certified (PMEC) Six Sigma Black Belt, Green Belt, and Yellow Belt Marketing Strategy Fundamentals Corporate Sales Fundamentals Scrum fundamentals Certified (SFC) Negotiation Associate Certified MBA in a box: Business Lessons from a CEOProfessional Education: Bachelor of Science (Engg.) graduate in Electronics and Communications from Magadh University, India.Products/Machines: Personal Protective Equipment (Medical, industrial gloves, and Apparel) Several type of calibration Gages. Calibration department tools and machines (C-Vision, Hurco etc.) Orthopedic Hips, Knees, Femoral, Packaging, R&D etc. product and equipment's. Manufacturing machines (CNC, C-Vision, Hurco, EDM etc.) Software testing webWork Experience:Actalent Engineering and Science, USA (Feb 2021 to present) Customer: Kimberly ClarkRole: Project ManagerProject / Program/Portfolio: Apparel & Gloves (medical &Industrial) Personal Protective Equipment. 3 Successfully accomplished planning, executing, monitoring, and controlling of product design, validation, and verification of the global launch PPE apparel of a branded, well-known multinational company. Managed to Update Master Tracker, issue log, Risk Register, Lesson Learned log, Stakeholder register and communication log. Coordinated with team during supplier selection and monitored the quality compliance and social compliance screening during the supplier selection. Coordinated in planning and monitoring during the client and supplier design and patter specification of the base sheet and the converter. Coordinated with team during Planning, Execution, and monitoring of Operation Qualification (OQ) and Performance Qualification (PQ) of the apparel base sheet and convertor. Worked with a team in a collaborative environment and removed all the impediments during the entire project. Conducted a weekly team cadence meeting to resolve issues. Separate meetings were conducted to resolve team conflicts or any other impediments. Cadence meeting was conducted for all the open, due, and overdue action items. Biweekly reports were sent to all stakeholders. Team schedule issues were resolved through a small, quick, team meeting without disrupting the weekly cadence meetings.The outcome of the different projects satisfied the client's expectations by completing the project on time and improving the quality of client documents.Real Staffing, USA (December 2018 Feb 2021)Customer: Johnson & Johnson (J&J), Warsaw, INRole: Project Lead In this role, I looked after multiple strategic projects, coordinated Quality Assurance and validation activities including CSV-E on multiple strategic projects. Coordinated third- party vendor and taking care of all Project activities such as organizing, planning, execution, and production support. Accomplished the audit Remediation project before the due date by my innovative ideas and reduced the cost and time of the project. Played a vital role in a closer writeup audit project in the ETQ system. Analyzed and highlighted preventive measures for opportunities to reduce the cost of quality. Maintained all the activities related to Master Control. Also, developed tentative/final operating criteria, procedures, protocols, and any other communications pertaining to QMS (Quality Management System). Team leading a cross-functional group in improving processes across the business. Audited all creation modification form project and organized all the documents in the ERP system. Planned and directed improvement activities for the current process, equipment, material, and product to meet customer needs. Plan, Track, and create reports and matrix of all my current projects.4 Review monthly overdue gages / Creation modification form, generate quarterly QPR (quality Progress Report) and matrix of the calibration department. Apart from my project and routine assigned work, I also contribute and provide necessary help which is required to my department in different other projects. Modis Engineering, USA (August 2016 December 2018) Customer: Zimmer Biomet, Warsaw, INRole: Sr. Quality Engineer Successfully accomplished CAPA, Remediation, nonconformance, HHED (Health Hazard Evaluation Determination) project. I successfully completed Calibration of Inspection, Measuring, and Test Equipment investigation. I reviewed the nonconformance. Successfully Investigated out of tolerance gages, reviewed, and closed the NC. In this role, I have completed IQ, OQ, PQ, and CSV-E on new and existing equipment. Experience on Manufacturing Transfer and hands on experience in a machining environment. Worked on NC (nonconformance) - Investigate NC, Confirm the Non-Conformance details, and move the Product Disposition to plan. NC investigation and Action Creation and Implementation for planned and non-planned. Investigate the use of using an out of tolerance measuring test equipment or gage for impact on equipment, process, and product. Issued and Investigated non-conformances using a systematic approach to problem-solving, conducted risk analyses, and recommended and oversaw the implementation of corrective and preventative actions with the goal of assuring quality and minimizing risk to the consumer. Successfully quality hold of, NCR, HHED, Validation, CAPA, assess the impact and scope OOT cases have on production and validation. Coached peers on ETQ and HHED project. Instru-Med Inc., USA (June 2016-August 2016)Role: Quality Engineer In this role I Maintained corporate controlled Document (CCD). Worked on Routing complaints, Corrective and Preventive Action (CAPAs), Non-conforming Material Record (NCMR), maintaining calibration/certificates, maintaining weekly metrics for production and quality departments, extracted from enterprise resource planning (ERP) and Quality Management System (QMS) software records, including production orders by department; complaints, gage R&R, CAPAs and NCMRs opened/closed; and quality metrics of orders shipped. Also, worked on Gage R&R, control plans (due to Print changes and / or changes in outsource supplier(s)People Link Staffing Solutions, USA (November 2015 May 2016) Customer: Avalign Technologies, Warsaw, INRole: Quality Engineer Worked as an engineering and quality role in this organization. Updated work instructions and routed for approval in the QMS system. 5 Audited the router folder, updated prints, and maintained engineering files electronically in the ERP system. Harmonized the two companys quality documents. Worked on spreadsheets to manage the quality department Risk Management PFMEA, Measure Protocol, etc. I worked on the changes made in the Company's new logo, Procedures. Instru-Med Inc., USA (July 2015-October 2015)Role: Quality Engineer, Warsaw, IN Worked for the Organization of Device History Records (DHRs). I Inspected several orders, routed to receiving or final component inspection operations, per inspection check sheet requirements (100% or at the acceptable quality level (AQL)), locating inspected part features on the customer print. Routing complaints, Corrective and Preventive Action (CAPAs), Non-conforming Material Record(NCMR), maintaining calibration/certificates. Maintaining weekly metrics for production and quality departments, extracted from enterprise resource planning (ERP) and Quality Management System (QMS) software records, including production orders by the department; complaints, gage R&R, CAPAs and NCMRs (Non- Conforming Material Report) opened/closed, and quality metrics of orders shipped. Adecco, USA (March 2015-June 2015)Customer: Zimmer Biomet, Warsaw, INRole: Inventory Analyst Provided statistical report to distribution management personnel and exhibit a high degree of detail and analysis when formulating decisions and recommendations. Managed Inventory restrictions and par levels as required to monitor inventory deployment. Updating daily weekly and monthly reports, scorecard, Distributor B/O (Business Objects) report, Expired Spreadsheets update and run a macro, Power ranking, MBR (Monthly Business Review) scorecard, Field Inventory Scorecard, Maintain/Cancel orders, DI reduction, Distributor DI charges, Processing Exchange form. Managed to run, Macro and update the daily report and Execute product obsolescence, expired, or transfer plans to ensure smooth transitions are met. Performed intermediate to advanced statistical analysis, add, subtract, multiply, and divide into all units of measure, using whole numbers, common fractions, and decimals. Effectively presented all the information to management. Perform related duties and project assignments as required.Adecco, USA (January 2015-March 2015)Customer: Zimmer Biomet, Warsaw, INRole: End User Administrator Provided L1 and L2 customer and technical support, including how-to questions, to customers through inbound phone and email requests.6 Independently identify, troubleshoot, documents, and replicate simple to complex customer problems and then resolve or escalate to L3 support team on complex issues as per defined escalation procedures. Retained ownership of the customer relationship on all cases throughout the resolution process which required follow-up with customers and involvement with other IT groups. Reports enhancement requests and defects received from customers on hardware, application, or documentation and communicates to the right IT team. ID and access management on approved Service Requests. 3GSOFT Solutions, India (April 2006-March 2007)Role: Quality Software Test Engineer Perform different types of testing (functional, acceptance, browser compatibility, load, stress, performance, and volume), Silk Test, Win Runner, Load Runner, Test Director on Microsoft desktop and server operating systems. Executed different testing and generated results e.g., functional, installation, acceptance, browser compatibility, load, stress, performance, and volume etc. Wrote and executed test cases. Also, developed execution plans and URS. I successfully did the Verification and validation of software. Reviewed SDLC documents, Risk assessments and any other information required as part of the software Validation process. |
