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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Software Quality Engr II - Exempt - **Company:** Lancesoft, Inc. - **Location:** Lafayette, CO, United States - **Experience:** Starter - **Contract:** Permanent contract - **Skills:** Testing (Software), Agile Methodology, Artificial Intelligence, Software as a Service, Software Quality, Software Engineering, Software Requirements Analysis, Software Systems, Verification and Validation (Software) - **Published:** September 19, 2026 - **Apply:** https://www.careerjet.com/job/usc7284273241907f1c5684315be5de3db/eaa ## About the Role * Expertise in computer and software validation and change control of Medical Devices. * Understanding of medical device regulations, including EU MDR, ISO 13485, and IEC 62304, and the ability to keep devices compliant with evolving regulations. * Experience with non-medical product development processes and lifecycle requirements. * Ability to serve as the voice of the Software Systems function, providing guidance from a software and systems perspective. * Expertise in training development and delivery. * Broad understanding of medical device development, regulation, and approval in the EU and US. * Familiarity with emerging AI-related standards and requirements. * Expert-level process development skills for creating quality system documents for diverse users and product types. * Advanced understanding of design controls, quality system regulations, and failure investigation methodologies. * Ability to apply design control principles and quality engineering techniques throughout the product development process. * Proficiency in defect analysis and the design and implementation of quality testing and validation tools. * Experience in developing and implementing processes and procedures. Nice to Have: * 0-3 years of medical/clinical experience or exposure. * 2 years of Medical Device experience. * Experience with Agile QMS and Cloud Based Software. * Knowledge of NC/CAPA., * Bachelor's degree required. * Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience. Be a part of our team and contribute to the development of cutting-edge medical device software in a collaborative and innovative environment in Lafayette, CO. ## Description Join our dynamic team in Lafayette, CO, where innovation meets quality. We are seeking a Software Quality Engineer to support both Medical Device software development and commercially available software products. This hybrid role offers the opportunity to work onsite four days a week, collaborating with cross-functional teams to ensure the highest standards of software quality and compliance., Responsibilities may include the following and other duties may be assigned: * Develop, modify, apply, and maintain standards for software systems quality operating methods, processes, and procedures. * Conduct evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification, and validation. * Define appropriate measures to ensure product quality. * Develop overall operating criteria to ensure implementation of the software quality program according to project, process, and contract requirements and objectives. * Ensure that projects and process control documentation are compliant with requirements and objectives. * Review software systems design, change specifications, and plans against contractual and/or process requirements. * Provide or direct verification and validation of software system requirements, traceability, and testability., Description : Duties: Performs a variety of systems administration and support tasks, including monitoring, analyzing, reporting and tracking, auditing, constructing, documenti… + 1 month ago + ## Related Videos - [Let’s Talk Quality!](https://www.wearedevelopers.com/videos/100012-let-s-talk-quality) - [Let's Talk Quality! - Lilia Gargouri](https://www.wearedevelopers.com/videos/1815-let-s-talk-quality-lilia-gargouri) - [ShapeShift: Reinventing Agile for a B2B SaaS Scale-Up](https://www.wearedevelopers.com/videos/1655-shapeshift-reinventing-agile-for-a-b2b-saas-scale-up) - [Rethinking Intelligence: AI, Accessibility, and the Future of Inclusive Work - Artur Ortega](https://www.wearedevelopers.com/videos/1377-rethinking-intelligence-ai-accessibility-and-the-future-of-inclusive-work-artur-ortega) - [The Affordances of Quality](https://www.wearedevelopers.com/videos/1134-the-affordances-of-quality) - [Security Pitfalls for Software Engineers](https://www.wearedevelopers.com/videos/726-security-pitfalls-for-software-engineers) ## Related Articles - [The 8 Best Code Testing Tools](https://www.wearedevelopers.com/magazine/402-the-8-best-code-testing-tools) - [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs) - [What is Software Engineering?](https://www.wearedevelopers.com/magazine/289-what-is-software-engineering) - [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again) - [The 12 Best Jobs for Software Engineers](https://www.wearedevelopers.com/magazine/401-the-12-best-jobs-for-software-engineers) - [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development)