Demo

Software Quality Engineer

Global Technical Talent
Irving, TX Full Time
POSTED ON 4/21/2025
AVAILABLE BEFORE 5/20/2025

Job Title : Software Quality Engineer - Senior or Lead

Contract Duration : 12 Months

Pay rate : Upto $46.76 / hr

Location : Irving, TX

Work Type : Onsite

Synopsis :

  • The Software Quality Engineer is responsible for ensuring that validation projects strictly adhere to all 21 CFR Part 11 requirements, including validation, data integrity, cybersecurity, periodic reviews, change management, CAPAs, and audit support.
  • This is a compliance-focused role, where the individual acts as the division's subject matter expert for the non-product software lifecycle policy and procedures.
  • They review and assess software activities (e.g., supplier evaluations, lifecycle deliverable documents, etc.) to ensure compliance with applicable procedures, standards, and regulatory requirements. They also direct multi-site and division-wide software lifecycle activities to achieve quality system objectives.
  • Reporting to the Director / Manager of division Compliance for Non-Product Software Validation and Cybersecurity, the individual is expected to interact frequently with senior management, requiring high competence, confidence, and credibility.
  • Software Quality Engineers are accountable for the project scope and ensure completion within budget constraints and scheduled deadlines.

Minimum Education / Experience :

  • Bachelor's with 8 years of exp. or Master's with 5 years of exp. (Required : Resumes must include the candidate's Bachelor's or Master's graduation year.)
  • Top 5 Skills / Requirements :

  • Prior experience in a regulated industry - GxP systems
  • Good knowledge of FDA regulations; 21 CFR Part 11, 820, Annex 11, GAMP5, ISO 13485, and ISO 27001.
  • Quality Management Tools and Test Management Tools - TrackWise / ComplainceWire / Veeva, ALM, JIRA, etc.,
  • Knowledge about Data Integrity and prior audit support experience (Internal / External).
  • Experience working with Software as a Service (SaaS), Infrastructure as a Service (IaaS), Platform as a Service (PaaS), Commercial-off-the-shelf (COTS), and Custom applications.
  • Benefits :

  • Medical, Vision, and Dental Insurance Plans
  • 401k Retirement Fund
  • About The Company :

    Global Healthcare Innovator

  • We're a leading healthcare company dedicated to improving lives worldwide. Our diverse portfolio includes medical devices, diagnostics, nutrition products, and branded generics. We're committed to developing groundbreaking technologies that address critical healthcare challenges and empower people to live healthier lives.
  • Join our team and :

    Work on cutting-edge projects

    Contribute to global healthcare advancements

    Experience diverse cultures and geographies

    Client a rewarding career with a company that cares.

    25-16762 : #LI-GTT #gttjobs #LI-Onsite

    Salary : $47

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