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Design Quality Engineer IV

Company: The Judge Group
Location: Palo Alto
Posted on: January 8, 2022

Job Description:

Location: Palo Alto, CADescription: Our client is currently seeking a Design Quality Engineer IV Position: Software Validation Lead ConsultantLocation: Palo Alto, CADuration: 6+ months Contract Job Description: Mandatory- 8+ years of experience in managing computerized system validation projects in a Medical Device company. - Experience with common document creation / editing tools such as Word, Excel, Acrobat, Powerpoint, Google Docs, Sheets, and Slides -Good implementation knowledge on 21 CFR Part 11 Compliance, Data Privacy Software controls - HIPAA/GDPR -Good Knowledge on drafting. Requirement Specification, Design/Configuration Specification, Code reviews, Design review, Validation Plan, Risk Assessment, Validation protocol execution, Validation report,, Part 11 assessment, 21 CFR 820 applicability assessment - Excellent interpersonal skills working across multiple divisions and sites and external resources. - Strong customer service orientation and corresponding skills. - Excellent written and verbal communication skills. Knowledge on AAMI/ISO TIR80002-2:2017 and TIR36:2007- DesiredBachelors or Masters Degree. 2+ years of additional general Quality Assurance experience in SaMD (Software as a Medical Device).Contact:nyadav@judge.comThis job and many more are available through The Judge Group. Find us on the web at

Keywords: The Judge Group, Palo Alto , Design Quality Engineer IV, Engineering , Palo Alto, California

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