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Software Quality Engineer in Irving, Tx

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Software Quality Engineer

Akkodis Irving, TX (Onsite) Full-Time
Derived Salary: $100K - $160K/Year

Akkodis is seeking Software Quality Engineer for a Contract job with a client in Irving, TX. Responsibilities include ensuring compliance with software validation, data integrity, and cybersecurity requirements, while leading software lifecycle activities to meet quality system objectives and supporting audits.

Rate Range: $40/hour to $45/hour; The rate may be negotiable based on experience, education, geographic location, and other factors.

Software Quality Engineer job responsibilities include:

  • Ensuring compliance with 21 CFR Part 11, data integrity, cybersecurity, and other regulatory requirements for non-product software validation.

  • Acting as the subject matter expert for the division’s non-product software lifecycle policies and procedures.

  • Reviewing software activities such as supplier evaluations and lifecycle deliverables to ensure compliance with applicable standards and regulatory guidelines.

  • Directing multi-site and division-wide software lifecycle activities to achieve quality system objectives.

  • Supporting audits, both internal and external, and ensuring adherence to GxP and FDA regulations (21 CFR Part 11, 820, ISO 13485, ISO 27001).

  • Managing validation projects within budget constraints and scheduled deadlines, while interacting with senior management.

  • Utilizing Quality Management and Test Management tools such as TrackWise, ComplianceWire, Veeva, ALM, and JIRA to track project progress and compliance.

  • Ensuring proper change management and CAPAs (Corrective and Preventive Actions) are implemented throughout the software lifecycle.

Desired Qualifications:

  • Bachelor’s degree in a related field with 8+ years of experience, or a master’s degree with 5+ years of experience.

  • 8+ years of experience in the healthcare industry, with a focus on regulated systems (GxP).

  • Strong knowledge of FDA regulations, including 21 CFR Part 11, 820, ISO 13485, ISO 27001, and GAMP5.

  • Experience with quality management and test management tools such as TrackWise, Compliance Wire, Veeva, ALM, or JIRA.

If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis, or any questions, feel free to contact me at udbhav.mathur@

.

Pay Details: $40.00 to $45.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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Recommended Skills

  • Auditing
  • Change Management
  • Computer Security
  • Corrective And Preventive Action (Capa)
  • Iso 13485
  • Iso/Iec 27001

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Job ID: US_EN_6_977201_1565725

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