Software Quality Assurance Specialist II

Software Quality Assurance Specialist II

Software Quality Assurance Specialist II is responsible for ensuring that all computerized systems used in healthcare operations comply with regulatory requirements such as FDA 21 CFR Parts 11 and 820, and ISO 13485. This role is critical in maintaining data integrity, patient safety, and product quality through rigorous validation of software and systems.

• Involved in standardization of CSV processes across all sites in accordance with global, regional, and site‑level directives.
• Coach and mentor CSV engineers and other project personnel on procedures, forms, templates, and regulatory requirements, fostering a culture of compliance and continuous improvement.
• Knowledge of global regulations and standards, including ISO 13485, FDA 21 CFR Part 11, and Part 820.
• Provide support during regulatory audits and inspections, ensuring readiness and robust documentation.
• Lead the overall test effort by defining the testing strategy.
• Author and approve validation deliverables (e.g., validation plans and validation summary reports).
• Participate in periodic reviews of GxP systems and conduct risk assessments and impact analyses for both new and existing systems.
• Design and deliver training programs in a variety of formats focused on regulatory compliance, quality systems, and validation practices. Ensure all personnel involved in the CSV process are appropriately trained and their training status is up to date.
• Assist the Supplier Quality function as SME in supplier assessments as necessary.
• Report key CSV metrics to the global metrics team, contributing to enterprise‑wide performance tracking.
• Collaborate with cross‑functional teams (QA, IT, Manufacturing, R&D) to define system / business requirements, analysis, and validation strategies.
• Ensure all validation activities are conducted in accordance with Jabil CSV procedures and associated work instructions.
• Maintain the Master System Inventory, ensuring accurate tracking of all GxP systems.
• Ensure compliance with the company’s security policies and procedures.
• Perform additional duties and responsibilities as assigned, contributing to the overall success of the CSV program.
• Review and conduct requirements traceability to design specifications.
• Supervise and lead test development, dry‑running, execution, and post‑execution review.

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