Software Quality Engineer - Medical Devices

Job ID: 616806 Our client, a leading Medical Device company, is a seeking a Software Quality Engineer for their growing team. This position has the opportunity to work with cross-functional team members to support post-market software related activities - See below for other details Please note: This is an onsite role (no hybrid/remote option available) Top 3 Technical Skills: 1) 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. 2) 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. 3) 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. Job Description: Post Market Release lifecycle, such as remediation, CAPA, and other activities as assigned. 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. EDUCATION REQUIRED: Bachelor’s Degree in Engineering, Science or technical field with 2 years of work experience in Engineering and/or Quality (or Advanced Degree in Engineering, Science or technical field with 1 year of work experience in Engineering and/or Quality) Nice to Have Experience 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 preferred Excellent oral and written communication skills