Senior Software QA & Requirements Coordinator

Job Description: 

We are looking for an experienced Software Quality Assurance Specialist with strong Business Analysis skills to join our team. In this dual role, you will lead quality assurance efforts while taking a proactive role in defining, analyzing, and reviewing product requirements for software applications used in clinical diagnostic instruments, ensuring quality, compliance, and seamless functionality essential for clinical settings. 

Key Responsibilities: 

• Software Quality Assurance: 

• Develop, execute, and document comprehensive test plans and test cases to verify software functionality, performance, and compliance with industry standards and regulatory requirements. 

• Create test cases, validation plans, and traceability matrices specific to clinical and medical applications. 

• Manage bug tracking and oversee testing for compliance, usability, and performance for software interacting with diagnostic hardware. 

• Work with cross-functional teams to troubleshoot and resolve issues, ensuring high-quality standards throughout the development lifecycle. 

• Monitor and report on testing progress, and provide clear documentation of results, including defect tracking and resolution. 

• Business Analysis: 

• Define, document, and manage software requirements based on stakeholder input and regulatory needs, maintaining clear alignment with project goals. 

• Analyze and interpret complex business needs, translating them into detailed functional and technical specifications. 

• Facilitate cross-functional collaboration, ensuring development and quality assurance are integrated with regulatory requirements and client expectations. 

Qualifications: 

• Bachelor’s degree in a relevant field (e.g., Biomedical Engineering, Computer Science, Clinical Diagnostics). 

• Proven experience (5+ years) in software quality assurance, ideally with medical or clinical diagnostic applications. 

• Strong background in requirements gathering, analysis, and documentation. 

• Knowledge of regulatory compliance in the medical field (FDA, ISO) and risk management processes. 

• Excellent analytical skills, attention to detail, and experience with SQA tools and methodologies. 

• Proficiency in English; other languages are an advantage. 

Preferred Skills: 

• Experience and familiarity in automated testing tools such as QTP and Ranorex. 

• Experience with requirement management tools and quality management systems (e.g. JIRA, Jama, Azure DevOps Test Plans, MTM). 

• Prior work with medical devices or diagnostics companies. 

• Certifications in Quality Assurance (ISTQB) or Business Analysis (CBAP) are a plus.