Engineer Software

Emelie Ngoy

** **** *****

Cromwell, CT *****

Phone: 203-***-****, 203-***-****

Email: ********@*******.***

Objective

To secure a full-time position with a well-established company with a stable environment where I

can use my compliance expertise to add value

Education

Minnesota State University, Mankato- Mankato, MN

Bachelor of Science: Management Information System, December 2005

Professional Experience

Covidien (Tyco Healthcare) July 2007-Present

North Haven, CT

Validation Engineer

• Works closely with Software Engineers to ensure implementation and application of

Software Validation principles throughout the development process

• Ensures that software validation processes meet the requirements of the FDA, ISO, as well

as requirements for the company

• Ensures system compliance with FDA’s Quality Systems Regulation throughout the

implementation of system

• Defines schedules, assigns and communicates Software Validation activities and tasks.

• Actively participates in the execution, review, and documentation of software test cases

and associated results.

• Continues leading and directly supporting implementation and validation of different

software that are used in the company as part of automated processes.

• Leads different groups in creation of software requirements documents, risk assessments,

trace matrices, and test cases

• Prepare, Reviews and approves validation protocols

• Participate in the implementation of the Software Development Implementation and

Maintenance methodology (SDIM).

• Assists others in the application of SDIM methodology and other Software validation

concepts throughout the implementation of a system.

• Develops and designs test scenarios, and uses system validation tools to execute these tests

• Debugs failures seen during validation cycles, communicates the status of work, and

works with stakeholders to resolve those failures

Associate Quality Engineer

• Worked with product development teams to identify and implement effective process

control systems throughout the development of products

• Lead in the implementation of process controls, and CAPA systems

• Assessed any process change for impact on regulatory and business requirements

• Ensure that protocol and protocol reports were properly developed, and executed

• Investigated root cause of any product and/ or process deviations and developed a

proposed corrective action

• Participated in the implementation of product and process improvement methodologies

• Worked with design engineering in the completion of product verification and validation

Hewitt Associates April 2006-March 2007

Norwalk, CT

Set Up Configuration Analyst

• Responsible for reviewing and analyzing documents prepared by the Systems Analyst and

configured (using graphic user interface tools) the TBA System to fix a system defect or

complete a client request/change

• Completed high level testing to ensure no major defects are in the code.

• Executed test plan (including regression testing) by identifying/creating test participants and

performing calculations for expected results

• Determined if configuration performs accurately, reflects requirements, and has zero

negative impact to existing provisions

• Documented defects when actual results do not meet expected results

• Analyzed issues/defects and debugs the system when configuration is not producing expected

results

• Researched issues to determine if source of error is with the test data, test plan, or

configuration

Resolved issues with test cases or set-up and re-tests configuration

•

• Escalated issues as appropriate

Spherion January 2006-April 2006

Stamford, CT

Technical Support Analyst

• Assigned to work at Cablevision

• Guided customers through established Troubleshooting procedures to identify technical

problems on the Network

• Worked with DOS, Win 95,98,NT, ME, 2000, XP, and Apple/ MAC OS 8, 9, 10

• Used internet communications protocols to solve problems on the Network

• Set up email clients for customers on Outlook, Outlook Express, Mac mail

• Troubleshot hardware such as Modems, routers

• Updated customer information on database

Archer Daniels Midland (ADM) March 2004- December 2005

Mankato, MN

Quality Lab Technician

• Prepared and processed finished product samples

• Performed analytical testing using instrumental and wet chemistry procedures

• Recorded lab results in computerized database systems

• Ensured FDA/ISO compliance and plant policies/procedures in areas of responsibility

• Observed all safety precautions and regulations at all times in all areas where duties are

performed

Computer Skills

Language: Java, Oracle, SQL, Visual Basic.net

Application Software: Microsoft- Access, Excel, Front Page, PowerPoint, Word

Operating Systems: Windows 95/98/ME/NT/XP/Media Center/Vista/MS DOS

MAC OS 8, 9, 10

Language: Fluently speak, read, write French

References: Available Upon Request

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