Senior SAP Quality Assurance Specialist

23 hours ago

Hyderabad, Telangana, India Medtronic Full time
Careers that Change Lives

We're a market leader in medical technology and healthcare solutions, and we're growing every day. You can be proud to be a part of technologies that are rooted in our long history of mission-driven innovation. We support your growth with the training, mentorship, and guidance you need to own your future success.

The candidate should be a seasoned SAP professional with a proven track record in navigating both ECC and S/4HANA landscapes.

A Day in the Life

Lead the planning, design, and execution of SAP quality assurance (QA) and testing activities in compliance with FDA regulations and guidelines, ensuring the integrity and reliability of systems supporting regulated processes.

Develop and maintain test documentation, including test plans, test cases, test scripts, and validation protocols, to verify the functionality, performance, and security of SAP systems undergoing S/4HANA transformation and ECC enhancements.

Coordinate with cross-functional teams, including business analysts, developers, and project managers, to define testing requirements, identify test scenarios, and prioritize test execution based on business criticality and regulatory requirements.

Establish and maintain traceability between testing artifacts and regulatory requirements, ensuring that testing activities are aligned with FDA validation principles and standards.

Implement and maintain automated testing frameworks and tools for regression testing of SAP applications, leveraging industry best practices and continuous integration/continuous deployment (CI/CD) pipelines.

Conduct risk-based testing assessments to identify and mitigate potential risks to system quality, data integrity, and regulatory compliance throughout the S/4HANA transformation and ECC enhancement lifecycle.

Monitor and report on test progress, defects, and quality metrics to project stakeholders, providing timely updates on testing status and highlighting any issues or risks impacting project timelines or deliverables.

Coordinate user acceptance testing (UAT) activities with business stakeholders, ensuring that UAT scripts are developed and executed according to defined acceptance criteria and FDA validation requirements.

Collaborate with IT infrastructure and security teams to ensure that testing environments are properly configured and secured to support SAP QA and validation activities in compliance with FDA regulations.

Provide leadership and mentorship to QA and testing team members, fostering a culture of quality excellence, continuous improvement, and knowledge sharing within the organization.

Stay current with SAP technologies, FDA regulations, and industry trends related to quality assurance and testing in regulated environments and apply this knowledge to drive innovation and efficiency in testing processes.

Participate in audits and inspections by regulatory agencies or internal quality assurance teams, ensuring that testing documentation and processes adhere to FDA validation principles and standards.

Travel to client sites or project locations as needed to support SAP QA and testing activities and engage with project teams and stakeholders.

Must Have: Minimum Requirements

14+ years of experience with a bachelor's degree or 8+ years of experience with an advanced degree.

Minimum of 5 years of experience in SAP quality assurance (QA) and testing, with a focus on S/4HANA transformation and ECC enhancements in FDA-regulated environments.

Expertise in developing and maintaining test documentation for SAP systems, including test plans, test cases, and validation protocols, in compliance with FDA regulations and guidelines.

Proficiency in any SAP testing tools and methodologies, such as SAP Solution Manager, HP ALM and Tricentis (Application Lifecycle Management), or similar tools for test management and defect tracking.

Hands-on experience with automated testing frameworks and tools for SAP applications, such as HP UFT (Unified Functional Testing), Selenium, or similar tools for regression testing.

Experience coordinating user acceptance testing (UAT) activities with business stakeholders, ensuring that UAT scripts are developed and executed according to defined acceptance criteria.

Experience working across US and multiple time zones.

Excellent communication skills with the ability to collaborate effectively with cross-functional teams and stakeholders in a regulated environment.

Nice to Have

Previous Medical devices and/or Pharma experience

Strong understanding of FDA validation principles and standards for computerized systems in regulated environments, including 21 CFR Part 11 compliance requirements.

Knowledge of SAP technologies and modules, with a focus on S/4HANA and ECC, including SAP modules relevant to FDA-regulated processes (e.g., QM, PP, PM).

Familiarity with IT infrastructure and security requirements for SAP testing environments in FDA-regulated environments, including data integrity, access controls, and audit trails.

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