Engineer, Software Quality - Senior or Lead

Title: Engineer, Software Quality - Senior or Lead

Location: Irving, TX

Duration: 12 Months

Requirement

• Candidates must have prior experience working in healthcare industry (Pharma/Biotech). Software Testing/Automating Testing profiles are not required
  
  

Synopsis –

• The individual 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, 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. They are accountable for the total project scope and ensure completion within budget constraints and scheduled deadlines.
  
  

Education min. / Experience min.- -

• 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 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 – Track Wise/ Compliance Wire/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
  
  

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.