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Software Design QA: 22-05864

Santa Clara, CA 95051

Posted: 01/25/2023 Job Category: Software Engineering Job Number: 18039226

Job Description

Primary Skills: Design Quality Engineering, IEC 62304, 21 CFR 820
Contract Type: W2 only
Duration:  12 months contract
Location: Santa Clara, CA (Hybrid)
Pay Range: $61 - $86 per hour

 
NOTE: Role open to Women Back to Work candidates with a career gap
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TALK to a recruiter NOW: CONTACT Waseem Khan at (408) 512-2364
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Work for a market leader!

 
JOB RESPONSIBILITIES:
  • Work in a cross-functional team in new product development and/or sustaining products covering emerging technologies in digital Health, health software, Software as a medical device (SaMD), MDDS and clinical Decision Support (CDS).
  • Support GxP impacting software systems as well as Computer Systems in accordance with CSV/CSA guidelines.
  • Quality SME in the review of all documents related to design control activities, providing feedback to ensure compliance and audit ready before approving them.
  • Participate in the ongoing implementation of the Quality Management System (QMS) in conformance with US FDA Quality System Regulations, 21 CFR 820, ISO 13485, IEC 62304, and Computer system assurance principles.
  • Primary Quality Lead in review of Design History file for completeness and adequacy at design reviews and provide inputs to GxP assessments for 21 CFR part 11/data integrity requirements.
JOB REQUIREMENTS
  • 5+ years’ experience in Software Design/ Quality Engineering.
  • Hands-on experience with ISO 62304, medical device software Life Cycle process
  • Working knowledge of 21 CFR 820, ISO 13485, ISO 14971, 21 CFR Part 11, GAMP5, electronic record, and electronic signature
  • Experience with digital health or digital IT & Experience in GxP computer systems
  • Experience working on low and high-risk software applications using a scalable approach to the SDLC practices and the QMS.
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CALL NOW: Waseem Khan at (408) 512-2364
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ABOUT AKRAYA

Akraya is an award-winning IT staffing firm and the staffing partner of choice for many leading companies across the US. Akraya was recently voted as a 2022 Best Staffing Firm to Temp For by Staffing Industry Analysts and voted by our employees and consultants as a 2022 Glassdoor Best Places to Work.

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