Job Description

We are seeking a Software Quality and Test Engineer to support our software testing and validation efforts. This role involves coordinating and managing system and acceptance tests, ensuring compliance with regulatory standards, and driving continuous improvement in testing methodologies. The ideal candidate will have extensive experience in software testing within regulated environments and a strong understanding of the software development lifecycle (SDLC).

Essential Duties and Responsibilities

Review requirements and specifications; define test conditions.
Design test cases and scripts mapped to criteria; record and report outcomes.
Analyze and report test activities and results.
Identify and report issues and risks related to own work.

1.
Quality Assurance

Collect evidence, conduct reviews, and/or compliance checks.
Verify that testing and quality control activities meet organizational standards.
Identify non-compliances and abnormal occurrences.

2. Relationship Management

Implement stakeholder engagement and communication plans.
Manage resolutions, corrective actions, and lessons learned.
Collect and use feedback from customers and stakeholders.

3.
Problem Management

Investigate problems in systems, processes, and services.
Assist with implementing remedies and preventative measures.
Escalate issues promptly to avoid risk or cost.

4.
Business Skills

Plan, schedule, and monitor own work within deadlines.
Contribute to team efforts and understand role impact on business.
Apply analytical and systematic approaches to issue resolution.

Skills & Knowledge

Strong communication (verbal and written) and interpersonal skills.
Ability to design and execute tests accurately, traceable to requirements.
Critical thinking and problem-solving in fast-paced environments.
Knowledge of testing and validation in life sciences or regulated domains (GCP, Financial).
Familiarity with test management and defect tracking tools.
ISTQB Foundation or equivalent certification preferred.

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