Engineer Quality

Ronald A. Maldonado

**** ******* **** 201-***-****

Union City, NJ 07087 ****************@*****.***

Skills:

EQMS Software: TrackWise, InfinityQS, Crystal Reports, Spotfire, SharePoint, AS400, Infor XA

Languages: C++, Java, Visual Basic

Server Technologies: Windows, Apache Tomcat

IDEs / Tools: Apache Tomcat, MS SQL Server Studio, Eclipse IDE

Microsoft Office (Word, Excel, PowerPoint), Visio

Education/ Certification/ Training:

MBA with Concentration in Risk Management, Saint Peter’s University, Jersey City, New Jersey, May 2016

Bachelor of Science, Computer Science, Saint Peter’s University, Jersey City, New Jersey, May 2011

Training

TrackWise: Introduction to TrackWise, 2013

TrackWise: Technical Fundamentals, 2013

TrackWise: Introduction to Configuration and Administration, 2013

TrackWise: Intermediate Configuration and Administration, 2013

TrackWise: Crystal Reports Design, 2013

Work Experience:

Zimmer Biomet, Edison, NJ June 2016 – June 2017

Quality Engineer

Provided on-site consulting services to Zimmer Biomet in Warsaw, Indiana to help improve the quality system.

Developed and maintained product verification and testing documentation that consist with Zimmer Biomet system Regulation and compliant with both ISO 9000 and ISO 13485.

Ensured compliance to 21CFR Part 820.

Performed detailed analysis to ensure quality process and implement Corrective and Preventative Action (CAPA) for improvements if needed.

Escalated issues to the quality engineer department when there were discrepancies

Learned InfinityQS within two weeks.

Walked on different workstations to gather business requirement and transformed into technical.

Provided input into developing and modifying to meet client needs and develop business specification to support the modifications.

Bridged between business and technical personnel to ensure mutual understanding of process and application.

Analyzed and extracted specification limits data from engineer drawings and uploaded to the database.

Read and analyzed criteria to ensure quality process and meet compliant.

Determined project requirements from area procedures, process requirements and end user.

Added and edited Assignable Cause and Corrective Action Codes.

Set up hierarchy and relational database structure for data collection analysis.

Built group and items structure for parts, process, test, and other user defined items.

Reviewed projects, executed testing, and performed migrations.

Provided support in the production environment to the operators in daily basis.

Provided training to operators and new IQS project builders.

Ability to deliver, meet deadlines and have results.

Glemser Technologies, Bethlehem, PA Oct 2013 – Jan 2016

TrackWise Delivery Analyst/ Quality Engineer

Worked for Pfizer, JPH Pharma .

Implemented Spotfire for clinical trials .

Created several complex Cross tables, Bart Chart, Tree map, Line Chart.

Created data sources for creation reports.

Uploaded raw data to designed reports based on the requirements provided by the client.

Improved data by adding Property controls, Calculation, Filters, Function and summaries.

Conducted different meeting to gather business requirements from business users and translated to technical.

Maintained business requirements and aligned them with technical and functional requirements for TrackWise and crystal reports.

Identified and resolve issues in documents to ensure business requirements.

Developed and updated Crystal summary and metrics reports to support the global Audit Management System TrackWise system.

Worked with the validation team to address formatting and defects during validation dry runs and formal execution.

Supported the current global Quality Tracking System (QTS) through configuration verification.

Analyzed and developed complex reporting requirements based on TrackWise configuration and authored of crystal reports for detailed and summary reports.

Co-configured and developed summary and metrics crystal reports for clinical. TrackWise systems.

Supported validation activities and executed system test scripts and resolved defects reported by the validation team.

Performed a manual re-key of TrackWise configuration between environments in place of the TrackWise migrator tool and documented discrepancies in documentation between configurations.

Performed TrackWise system upgrades from version 8.25 to version 8.7.Documented upgrade procedure and required installation qualification documents to support the upgrade and meet the business requirements.

Established new TrackWise migration snapshots and performed unit testing to ensure required functionality was maintained as a result of the upgrade.

Conducted analysis of TrackWise 8 including hands on prototype workshops to determine business requirements and implemented the related configurations for the CAPA business process area.

Implemented different process group such as Change Management, Commitment Tracking, Complaint Investigations, Lab investigations, Manufacturing Investigation.

Documented all the process group, support validation team by addressing any defect immediately.

Developed and tested different complex crystal reports, audit reports, investigation reports, manufacturing reports, parent child reports.

United Teletech Financial, Tinton Fall, NJ Sept 2012 – Mar 2013

Software Implementation Engineer

Performed and assisted different projects on daily basis

Generated SQL reports and queries for the lending, accounting, and operation department from the source database Refreshed the reports and updated the values for monthly statements and transactions

Analyzed the data by creating and using advanced Excel formulas Worked with the Visual Basic language to develop Excel macros and updated all the new opened accounts and loans weekly

Provided support in the event of a software failure and helped to assist the network team Developed and tested the workflows that ran automatically and emailed to their perspective department including: collection and accounting

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