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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Senior Design Quality Engineer - Medical Devices - Chicago, IL in Chicago - **Company:** Energy Jobline - **Location:** Chicago, IL, United States - **Experience:** Expert - **Contract:** Permanent contract - **Skills:** Failure Mode Effects Analysis, Integrated Development Environments, Iq/oq/pq, GXP - **Published:** September 4, 2026 - **Apply:** https://www.energyjobline.com/job/senior-design-quality-engineer-medical-devices-chicago-il-chicago-31465944 ## About the Role * Able to work in the office at least 3 days a week * Bachelor's degree in engineering, science, or relevant field * 5+ years relevant work experience * Proficiency with FDA 820 CFRs/ISO 13485/cGMP quality management system and requirements for medical devices and/or combination product development and manufacturing * Proficiency with ISO 14971 and application of risk management to the development of medical devices and/or combination products * Experience with electromechanical medical devices and IEC 60601 * Strong preference for experience in pharma or medical device manufacturing and/or development environment; Strong preference for electromechanical systems based experience * Experience using risk analysis and continuous improvement concepts * Experience with GxP requirements * Experience supporting audits * Strong technical written and verbal communication skills * Excellent interpersonal, change management, planning, and organizational skills * Excellent oral, written, and presentation communication skills Personal Attributes: * Meets Gilero Core Values: Collaboration and Innovation of Excellence and Integrity * Productive in a fast-paced, entrepreneurial environment. * Commits to excellence and quality service to external and internal customers. * Adheres to established policies and procedures, while contributing to continuous improvements. ## Description * Represent Quality in cross-functional development teams, providing direction for development through transfer to production activities. * Author, maintain, and ensure compliance of Design History File documents during the development process in accordance with ISO 13485. * Translate user needs, intended use, regulatory inputs, and risk controls into measurable product requirements, specifications, and acceptance criteria. * Support design verification and validation activities, including statistical approach and analysis * Support project related efforts with quality system elements (CAPA, Complaints, Supplier Management, External Audits, etc.). * Participate in and facilitate risk management activities (hazard analysis, FMEAs, and risk assessments per ISO 14971) * Ensure traceability and testability of design requirements and risk controls. * Support manufacturing transfer, including review of preparation and execution of process validation (IQ/OQ/PQ) protocols, and development of production inspection plans. * Investigate, disposition, and resolve nonconforming material events during product development And pre-production phases; support production phases for transferred programs as needed. * Act as technical expert (including potential author) for new or revised QMS procedures; May include train team members, and release quality system procedures, as required. * Support internal and external audits (particularly for projects), as required with help of broader quality management team * Support supplier selection, qualification, and ongoing monitoring with help of broader quality management team. * Facilitate investigations to determine root cause and failure modes. * Execute quality event initiation, investigation, and closure for nonconformances, CAPA, change control, and complaints as required. ## Related Videos - [Blueprints for Success: Steering a Global Data & AI Architecture](https://www.wearedevelopers.com/videos/1577-blueprints-for-success-steering-a-global-data-ai-architecture) - [What Production Knows: Closing the Loop Between AI Agents and the Systems They Build](https://www.wearedevelopers.com/videos/100277-what-production-knows-closing-the-loop-between-ai-agents-and-the-systems-they-build) - [More efficient software for more efficient microchips](https://www.wearedevelopers.com/videos/1164-more-efficient-software-for-more-efficient-microchips) - [Great DevEx and Regulatory Compliance - Possible?](https://www.wearedevelopers.com/videos/1426-great-devex-and-regulatory-compliance-possible) - [Designing How Work Feels: The Science Behind Sanofi’s Workplace Experience](https://www.wearedevelopers.com/videos/1848-designing-how-work-feels-the-science-behind-sanofi-s-workplace-experience) ## Related Articles - [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development) - [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs) - [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) - [Where To Find Software Engineering Jobs](https://www.wearedevelopers.com/magazine/396-where-to-find-software-engineering-jobs) - [Top Characteristics of a Software Engineer](https://www.wearedevelopers.com/magazine/166-top-characteristics-of-a-software-engineer) - [Welcome to Switzerland](https://www.wearedevelopers.com/magazine/4-welcome-to-switzerland)