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).
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