Software Quality Engineer

Software Quality Engineer with a strong background in Requirements analysis, software documentation & Specification, Software QA & Compliance

Will support Post Market Software related activities: remediation & CAPA.

Responsibilities may include but not limited to the following activities, with mentor/coach/guidance from more senior Software quality engineers:

• Supports product quality ensuring the implementation of cutting-edge technology for medical devices is safe, effective, and compliant with regulations, standards, and industry practices.
• Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation.
• Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts.
• Reviews software systems design, change specifications, and plans against process requirements.
  
  

Collaborate with test engineering on verification and validation strategies, review and approve test protocols and reports.Excellent oral and written communication skills

Job Requirements

Required: Bachelor's Degree in Engineering, Science or technical field

2 years of e xperience in the medical device industry

• Experience with FDA Quality System Regulations, Medical Device Directive, ISO 13485, ISO 14971, and ISO 62304 standards
• Navigation systems experience
  
  

Top 3 technical skills that are required for the role:

• Requirements Analysis and Management: This skill is crucial for evaluating product definition requirements, ensuring that software product requirements are clear, complete, and testable, and assessing test coverage with respect to requirements and design outputs.
• Software Documentation and Specification: The ability to review and remediate design output documentation, such as software architecture documentation and software form and behavior specifications, is key. This includes ensuring these documents meet intended use and performance criteria.
• Quality Assurance and Compliance: Knowledge and experience in quality assurance practices, especially related to following Quality System Practices and meeting FDA, ISO, and European Medical Device standards and regulations, are essential. This includes identifying design-related gaps and implementing mitigation strategies