SQA Validation/Test Consultant in Alameda, CA at Johnson Service Group

Date Posted: 12/3/2020

Job Snapshot

Job Description

JobID: 381274

JSG is seeking 2 Validation/Testers with experience with Life Science organizations for a long term consulting engagement.  This role will be remote during stay at home orders but will be onsite once the restrictions are lifted.  

NO THIRD PARTIES!  LOCAL ONLY!

Experience Required:

# 4-5 years SQA experience in Medical Device, Regulated environment such as FDA and worked under corporate quality systems

# 2+ years of working knowledge experience in writing and review of protocols, execution, generating traceability matrix especially in DOORS and HPQC
 

# Must have experience in review of product SWQA documentation for accuracy, clarity, consistency,  completeness and compliance. Including System Specifications/Requirements  documents, Validation protocols, Trace Matrices and Validation Summary Reports# Must able to execute SWQA tasks in a timely and efficient manner

# Working knowledge experience of DOORS, HPQC, Defect Logging using HPQC, MKS etc.,


#Has worked in Medical Domain and is familiar with ISO13845, 21 CFR Part 11

#Agile Document Management System experience a huge plus 

Must Have:
4-5 years experience
Bachelors Degree required

#D800




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