Hi,

Hope you are doing well.

Please go through the below job description

and let me know your interest for the below  role.

*Tester with  Knowledge of testing medical products, Milwaukee WI*



*Mandatory Technical Skills:*



• Experience as a Verification and Validation Engineer for 5+ years

• XRAY product testing experience [System Testing experience mandatory]

• Strong knowledge of Microsoft Windows technologies

• Strong belief in quality compliance and following rules

• Strong working experience on setting up lab test equipment and setting up
PC and Servers and deploying software onto target systems

• Knowledge of testing medical products

• Knowledge of FDA regulations required to test medical products

• Expertised in quality reviews



*Desirable Technical Skills:*



• Prepared, reviewed, executed and summarized validation protocols

• Served as a technical resource for assessing validation requirements,
solving test related problems, and developing strategies for problem
prevention

• Provided validation support for the review to ensure designs comply with
current validation standards and are able to be adequately validated and
maintained within validated control

•  Experienced in Software Development Life Cycle (SDLC) Waterfall and
Agile methodologies, Manual Testing, White Box and Black Box Testing,
Validation and Verification testing.

• Experienced in testing Software, Web Applications, IVR, System
Components, and Database

• Experienced in System Performance, Unit, Functional, Regression,
Integration and User Acceptance Testing.

• Participated in writing and implementing Test Plans, Test Cases and Test
Scripts/Protocols and Traceability Matrix. Executed Test Scripts/Protocols
and documented Test Results. Edited and re-tested Test Scripts/ Protocols
and signed off (Pass/Fail)

• Participated in Requirements gathering, Code Reviews/ Walk Trough.

• Hands-on experienced in Automated Test Tool –Mercury Win Runner, Load
Runner and Test Director.

• Created defect tracking (manual repository), maintained and updated
defect statuses and timelines.

• Exposure in Risk Assessment and Testing Methodologies.

• Exposure to Protocol Creation, Execution –IQ, PQ

• Complaints Investigation for Medical Device  (CAPA)

• Exposure in FDA Regulations  – GMP, CGMP, GAMP, GXP, QSI, 21 CFR Part 11
and CFR Part 820, ISO 14971,  Risk Assessment for Medical Device, ISO
1345,  IEC 62304 – International Standards (Europe and US)

• and IEEE, SEI, Six Sigma and other ISO standards and regulations.









*Shivani Gaur* | SYSMIND, LLC

[image:
https://newoldstamp.com/editor/profilePictures/profile-b15c8fc3ea4630e2ca604f11e3e951c7-41898.png]

*Technical Recruiter*

Phone: 609-897-9670 x 2160

Email: shiva...@sysmind.com

Website: sysmind.com

Address: 38 Washington Road, Princeton Junction, NJ 08550

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