Senior Requirements Coordinator and Quality Assurance Engineer

Job Description:

We are seeking an experienced Software Requirements Coordinator with strong Business Analysis skills to join our team. A background in Quality Assurance is a plus. In this dual role, you will take the lead in defining and coordinating software requirements with global stakeholders, while proactively analyzing, reviewing, and refining product requirements for software applications used in clinical diagnostic instruments. Your work will ensure that our solutions meet the highest standards of quality, compliance, and functionality, critical for use in clinical environments.

Key Responsibilities: 

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. 

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.

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.