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SOFTWARE QA ENGINEER 3

Company: Veterans Sourcing Group
Location: Santa Clara
Posted on: November 25, 2022

Job Description:

Job Title: Software QA Engineer
Pay Rate: $80/hr
Location: Santa Clara, California
Duration: 11 month contract position

Summary:


  • This is not a Software testing role. This is a Software Design Quality assurance role.
  • As a part of this expansion this individual will support projects that fall within a new and growing team- Digital and data products.
  • As a part of this expansion, we are looking for an ideal candidate to possesses a broad base of experience and a high level of technical depth in individual who will be assigned to work on digital and data software medical and non-medical products
  • You will not abide "process red tape", instead passionately seek the most efficient way to build in product quality
  • As part of the role, you will work in a highly skilled, multi-disciplinary team who you will coach, mentor, teach and influence in best software Quality practices.
  • The primary focus of this position to support design teams tasked with development and delivery of these products from a Software Product Quality perspective
  • This is not a Software testing role


    Roles and Responsibilities:


    • This person will work in a cross functional team in new product development and/or sustaining products covering emerging technologies in digital Health, health software, Software as medical device (SaMD), MDDS and clinical Decision Support (CDS).
    • This person will also support for GxP impacting software systems as well as for Computer System in accordance with CSV/CSA guidelines.
    • This person will serve as product quality representative for software projects and will closely work with core team advising others on best practices in Quality control for software centric products.
    • This person will ensure that each project is developed and released meeting customer expectation consistent with QMS.
    • Participate as Quality Subject matter expert in the review of all documents related to design control activities, providing feedback to ensure compliance and are audit ready before approving them.
    • Author Master Validation Plan (MVP), Master Validation Report (MVR), Device performance summary report and procedure deviations.
    • Participate in 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.
    • Supports the risk management activities for software in compliance with ISO 14971 and Guides software development teams on cybersecurity Risk management activities in accordance with NIST guidelines.
    • Primary Quality Lead in review of Design History file for completeness and adequacy at design reviews.
    • Provide inputs to GxP assessments for 21 CFR part 11/data integrity requirements.
    • Able to articulate the latest and complex regulation to project team.
    • Able to understand the impact of regulations to our procedures and make the corresponding SOP/DOP updates.
    • Able to contribute to external audits, perform internal audits.
    • Assist with developing procedures when new digital products are design and developed in accordance with regulatory requirements and guidance's.
    • Expected to work independently, holding him/herself accountable to proactively fulfill tasks and achieve results within assigned timelines.


      Skills, Experience, Education, & Training:


      • Required: Education- 4-year degree in software, Biomedical, electrical, mechanical or system engineering or equivalent technical discipline. Advanced degree is also preferred.
      • Required: 5+ years' experience in Software Design/ Quality Engineering.
      • Hands on experience with ISO 62304, medical device software Life Cycle process
      • Working knowledge on 21 CFR 820, ISO 13485, ISO 14971, 21 CFR Part 11, GAMP5, electronic record and electronic signature
      • Experience in training, working collaboratively with software development teams.
      • 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.
      • Attention to details and Quality are critical to success.
      • Excellent organizational, interpersonal, and verbal and written communication skills, with the ability to deliver quality outputs under minimum supervision.

Keywords: Veterans Sourcing Group, Santa Clara , SOFTWARE QA ENGINEER 3, IT / Software / Systems , Santa Clara, California

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