The Software Quality Engineer works (hands on) on the validation of study software as well as reviews and approves the CSV package according to the SOPs and Work Instructions. The SQE is also responsible for the overall test effort, quality, timelines for assigned projects, taking ownership of the project and clearing any roadblocks that arise in day to day.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Reviews (Manuals/Specification): Demonstrated ability to successfully complete tasks in this competency as requested.
Review project relevant documents regarding testability, comprehensibility, plausibility, inconsistencies or quality gaps.
Work with internal stakeholders to understand project requirements, providing experience and guidance regarding project risk and possible mitigation actions.
Feedback of review results to internal department stuff and/or external teams.
Test Case Design: Demonstrated ability to successfully complete tasks in this competency as requested.
Definition of test case goals.
Using test techniques for defining test cases.
Definition of test cases with expected result (Integration test, functional test, performance test etc.).
Definition of prerequisites for a test case.
Traceability regarding requirements, test cases and test documents.
Collaborate with developer or study implementation manager to understand the changes in new software versions and identify the appropriate set of functional and regression tests needed to verify that new features work as designed and do not cause any undesirable behavior.
Test Execution: Demonstrated ability to perform the actions associated with this skill without assistance.
Execution of predefined test cases on SUT.
Creating meaningful test evidence (screenshots etc.).
Create and use suitable test data.
Test Result Analysis: Demonstrated ability to successfully complete tasks in this competency as requested.
Compare and assess expected with actual test result.
Identifying of deviations not stated in test documentation (violation of state-of-the-art and common sense expectations).
Identify and report deviations.
Test Reviews: Demonstrated ability to successfully complete tasks in this competency as requested.
Check test cases and their execution for completeness/correctness.
Check corresponding test documentation.
Check test cases for conformity and completeness regarding applicable/covered requirements.
Bug Handling: Demonstrated ability to perform the actions associated with this skill without assistance.
Entering meaningful bugs into the bug tracking system, which are detailed and reproducible.
Understand and apply bug life cycle.
Finds root causes of bug / quality problems.
Rating severity of bug.
Prioritized bug retesting.
Test Environment: Demonstrated ability to successfully complete tasks in this competency as requested.
Setup and maintain/update configured test systems for test execution.
This includes knowledge and use of applicable backend environments and dummy tools for testing purposes.
Test Documentation: Demonstrated ability to successfully complete tasks in this competency as requested.
Creation of all test documents needed for various test activities and applicable SOPs/procedures.
Provide necessary documents to support audits (internal, external and by regulatory agencies).
Follow all testing practices and procedures to meet regulatory compliance standards and Good Clinical Practices.
Project Reporting (status, escalation) (working on one Project): Demonstrated ability to successfully complete tasks in this competency as requested.
Report current status of assigned tasks/projects to next reporting level (current status = done/todo/#bugs).
Report current status of assigned tasks / projects to external parties.
Attending status meetings and report current status for projects.
Demonstrated ability to work under pressure and meet deadlines without supervision.
Manage fair workload and volunteer for additional work, prioritize tasks, manage time well.
Meets commitments, accepts accountability, sets personal standards, and stays focused under pressure.
Provide accurate and timely input in the reporting system.
Test Management (multiple projects): Demonstrated ability to successfully complete tasks in this competency as requested.
Assign Engineer to projects/tasks (onsite and offshore).
Plan test activities for upcoming testing projects (timeline and resources).
Monitor current running projects regarding status, timelines, risks
Recognizing and escalation project risks.
Monitor testing tasks about efficiency and quality. Do follow-up on defects in defect tracking system and update priority and assignment as needed.
Test Effort Estimations: Demonstrated ability to successfully complete tasks in this competency as requested.
Estimate test effort for upcoming testing tasks/projects.
Estimation of necessary prerequisite.
Test Data Management: Demonstrated ability to successfully complete tasks in this competency as requested.
Create and maintain necessary test data for positive/negative/border tests for different modalities (ECG, PFT, AM,etc).
Working with Test Tools: Demonstrated ability to successfully complete tasks in this competency as requested.
Work with established testing tools:
Screenshot applications.
Bug tracking system.
Document Management System.
Test Management System.
Test Automation Suite.
Continuously review department tools and provide guidance on tool improvements and/or efficiency.
Project Reporting (status, escalation) (working on multiple Projects): Must have a basic understanding of:
Report current status of assigned tasks / projects to next reporting level (current status = done/todo/#bugs).
Engineer must be able to handle complete planning of study tasks for multiple projects (2+).
Report current status of assigned tasks / projects to external parties.
Attending status meetings and report current status for projects.
Demonstrated ability to work under pressure and meet deadlines without supervision.
Manage fair workload and volunteer for additional work, prioritize tasks, manage time well.
Meets commitments, accepts accountability, sets personal standards, and stays focused under pressure.
Provide accurate and timely input in the reporting system.
Test Strategy/Concept Support: Must have a basic understanding of:
Proactively deliver insight views of testing tasks/study.
Participate in discussions on test approach for upcoming testing tasks (participate = suggest, confirm, discuss).
Participate in test strategy document creation.
Maintain a broad understanding of practices and developments in the Computing, Regulatory, Pharmaceutical and HealthCare industries.
Attend UATs, customer calls and audits (internal, external and by regulatory agencies) as needed.
Participate in Root Cause Analysis Sessions (CAPA).
Test Process Improvement: Demonstrated ability to successfully complete tasks in this competency as requested.
Provide proactively proposals to change, skip, add steps in the current applied test process to improve efficiency, effectiveness and quality.
Identification of inefficient or error prone processes or process steps.
Collaboration within/outside Department: Demonstrated ability to successfully complete tasks in this competency as requested.
Deliver presentations, share information and ideas with others.
Participate in cross-training activities (within and/or outside the department).
Mentor, train and monitor new co-workers and their progress.
Assist the department manager and contribute to departmental goals and efficiencies.
Cross-collaboration with other departments.
OTHER DUTIES AND RESPONSIBILITIES:
Demonstrates an ability to communicate and work with an offshore team when necessary.
Demonstrates an ability to work under pressure and meet deadlines.
Targets and achieves results, sets challenging goals, prioritizes tasks, overcomes obstacles, responds well to change.
Practice self-development. manages a fair workload, volunteers for additional work, prioritizes tasks, and manages time well.
Participates in cross-training activities, e.g. translations, formatting, package building/testing, etc.
Communicates well both verbally and in writing, leverages multiple modes of communication, is responsive and courteous in interactions, provides an appropriate amount of information and detail.
Is attentive to detail and accuracy, is committed to excellence, looks for improvement continuously, monitor quality levels.
QUALIFICATIONS AND SKILLS NEEDED:
Education:
BS, BA or equivalent in an Information Technology or related field required.
Experience:
1-3 years software testing experience
Intermediate understanding of Software Development Process
ISTQB Foundation Level (optional)
Ability to self-develop
Intermediate experiences with Clario Software/Hardware
Good English language skills (if applicable)
Novice knowledge of Test Automation (if applicable)
Novice knowledge of Agile Methodologies (if applicable)
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