Tester with Knowledge of testing medical products_Milwaukee WI

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
	Technical Recruiter Phone: 609-897-9670 x 2160 Email: shivanig@sysmind.com Website: sysmind.com Address: 38 Washington Road, Princeton Junction, NJ 08550

 

 

 

 

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