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Engineer Quality

Location:
Warsaw, Indiana, United States
Posted:
August 10, 2018

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Resume:

Mitul Singh

Address: **** ***** ***** ******, ******, IN 46582

Phone: 630-***-****(Home); 630-***-****(Mobile)

E-Mail: ac6mg5@r.postjobfree.com

Profile Summary:

Engineering graduate experienced in Quality Engineer, Quality Technician, Quality inspector,engineering tech,software testing domain, User Identity Management, Quality software engineer, End User Administration, and Inventory Analysis,. I also hold extensive knowledge of MS Office Suite with advance Excel. 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.

Education:

Bachelor of Engineering (Electronics & Communication)

College: R.P .Sharma Institute of technology

Certification:

1.Six Sigma Yellow Belt

2.Scrum fundamental

3.Negotiation Associate

4.C programming Language

.

Technical Skills:

SAP,CMS,ETQ,WOW, SERDAAK, JDE, ENOVIA, DOC .VIEW,PLOT VIEW,DCS, HMS, SALESFORCE, CRM, LIVELINK, MICROSOFT WORD, EXCEL, SQL, DCT TOOL, WORKFLOW, AS400, FASTPORTALO, C PROGRAMMING LANGUAGE, BWS, BMC REMEDY, EZACCESS, XA, JOB BOSS, MASTER CONTROL.

Professional Experience:

Zimmer Biomet - Quality Engineer (August 2016 –Still working)

CAPA project - Remediation of Gage Rejection notification (GRN) when gages Calibration fail.

Investigate the use a using an out of tolerance measuring test equipment or gage for impact to equipment, process, and product.

Calibration of Inspection, Measuring, and Test Equipment investigation and justification rational.

Create Calibration not require form for Equipment/Gage on the shop floor, investigate the gage /Equipment on shop floor and write the justification.

Write rational for Out of Tolerance gage.

Investigate the (Health Hazard Evaluation Determination) HHED GRN of failed calibration gages and write the investigated memo.

Worked on HHED project and no calibration require Test Equipment.

Trained the HHED team on ETQ.

Calibration of Inspection, Measuring, and Test Equipment investigation and justification rational for no calibration require for the equipment.

Peer Reviewer of the Remediated GRN.

Investigate the use a using an out of tolerance measuring test equipment or gage for impact to equipment, process, and product.

Write rational for Out of Tolerance gage.

Work on Gage Rejection notification (GRN), investigate and justify by evidence (IQ/PQ investigation).

Generate scope for OOT condition.

Generate multiples report from JDE scoping tool and CMS for scoping.

Investigate PQS form and rationalize.

Investigate and rationalize reconciliation form.

Create and investigate NCR.

Perform Quality hold.

Request Distribution history, hold and flag numbers.

Generate gage scan report.

Instru-med Inc. - Quality administrator (June 2016-August 2016)

Maintenance of Corporate Controlled Documents (CCD).

Initiating / routing of Complaints, Corrective and Preventive Action (CAPAs), and Non-conforming Material Records (NCMR).

Maintaining gage calibrations / certificates.

Updating control plans (due to Print changes and / or changes in outsource supplier(s).

Maintain 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, CAPAs and NCMRs opened / closed; and quality metrics of orders shipped.

Avalign Cutting Instruments - Quality Inspector/ Engineering Tech (November 2015 – May 2016)

Work Instructions and routed for approvals through the QMS system.

Work on spread sheets to manage the quality department changes as FDA Registration Spreadsheet, Risk Management – PFMEA, Measure Protocol etc.

Assess the impact and scope OOT cases have on production.

Ability to read analyzes and interpret company standard.

Updated Procedures and Work Instructions and routed for approvals through the QMS system.

Validate and make changes in Company new logo, Procedures etc.

Scan all job Travelers, Part number etc. and save at proper folder.

Implement QA systems and generate SOPs in support of FDA Regulatory requirements.

FDA Registration documents maintaining.

Updating Gages in system.

Audit the router folder.

Updating all prints electronically.

Maintaining and updating Engineering files electronically.

Pin gage project- MIS (criteria) change with current revision.

Instru-med Inc. - Quality Administrator (July 2015-October 2015)

Organization of Device History Records (DHRs)

Initiating / routing of Complaints, Corrective and Preventive Action (CAPAs), and Non-conforming Material Records (NCMR).

Maintaining gage calibrations / certificates.

Updating control plans (due to Print changes and / or changes in outsource supplier(s)).

Maintain 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, CAPAs and NCMRs opened / closed; and quality metrics of orders shipped.

Introductory experience with gaging ( calipers, micrometers, height stand, comparator)

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.

Updated Procedures and Work Instructions and routed for approvals through the QMS system.

Zimmer Inc. - Master Data coordinator, Sales Operations (April 2015- June 2015)

Validation of physician using sales force.com, HMS and updating in DCS.

Changing and creating new account in DCS.

Merge duplicate accounts.

Update existing physician.

Request physician to be validated.

Change bill to and ship to account.

Working on large spread sheets, cleanup of spreadsheet according to the format using in DCS.

Using a lot google for validation.

Knowledge of Live link.

Knowledge of Accepting assignment, validating sending to CFS and again making final update to DCS.

Knowledge of CSM, ACL etc. . . . screen

Biomet - Inventory Analyst (March 2015-April 2015)

Analyze inventory positions and provide statistical report to distribution management personnel

Exhibit a high degree of detail and analysis when formulating decisions and recommendation

Provide monthly and ad-hoc reports as required

Manage Inventory restrictions and par levels as required to monitor inventory deployment

Execute product obsolescence, expired, or transfer plans to ensure smooth transitions are met

Perform related duties and project assignments as required

Provide timely and accurate feedback and communication to all internal and external customers, peers, and management

Run Macro

Updating daily weekly and monthly reports, scorecard, Distributor B/O report, Expired Spreadsheets update and run macro, Power ranking, MBR scorecard, Field Inventory Scorecard, Maintain/Cancel orders, DI reduction, Distributor DI charges, Processing Exchange form

Perform intermediate to advanced statistical analysis, add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals

Effectively present all the information to management.

Zimmer Inc. - End User Administration (IT) (January 2015-February 2015)

Creations of domain ID in Active Directory as per directory structures and add to the requested access groups.

Add, Modify, and Revoke the access on different folders, and different tools e.g. – SAP, JDE, Live link, E-Mail ID creation in MS Exchange 2013, Enable MS Lync.

BMC Remedy and eZaccess – Both tools used as tracking of Incident and Service requests processing in the system.

3GSOFT Solutions– Quality Software Test Engineer (April 2006-March 2007)

Wrote and executed test cases.

Developed execution plans.

Executed different testing and generate results e.g. functional, installation, acceptance, browser compatibility, load, stress, performance, and volume etc.

Perform different types of testing (functional, acceptance, browser compatibility, load, stress, performance, and volume), Silk Test, Win Runner, Load Runner, Test Director Windows 7, Windows 8 Microsoft desktop and server operating systems, Microsoft Windows 95/2000/XP/Vista/7, Windows Server 2000/2003/2008, and Microsoft Office Pro Suite.



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