Location: Palo Alto, CA
Description: Our client is currently seeking a Design Quality Engineer IV

Position: Software Validation Lead Consultant

Location: Palo Alto, CA

Duration: 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-

Desired

Bachelor's or Master's Degree. 2+ years of additional general Quality Assurance experience in SaMD (Software as a Medical Device).

Contact: Click here to Apply?subject=Design%20Quality%20Engineer%20IV" rel="nofollow">Click here to Apply

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