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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Quality System engineer - **Company:** Katalyst Talent Agency - **Location:** Atlanta, GA, United States - **Experience:** Expert - **Contract:** Permanent contract - **Skills:** Document Management Systems, Failure Mode Effects Analysis, Microsoft Office, Iq/oq/pq, Performance Monitor - **Published:** July 12, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=efae821656820310 ## About the Role * Bachelor's degree in Engineering, Quality, Life Sciences, Manufacturing, or a related technical discipline. * 2 5+ years of experience in Quality Systems, Quality Engineering, or Quality Assurance within a regulated industry. * Knowledge of Quality Management Systems (QMS) and applicable regulatory requirements. * Experience with CAPA, Change Control, Deviations, NCRs, and Document Control. * Familiarity with FDA regulations, ISO 13485, ISO 9001, GMP, and 21 CFR Part 820/QMSR. * Experience participating in internal or external audits. * Strong analytical, problem-solving, and documentation skills. * Excellent communication and cross-functional collaboration abilities. * Proficiency with Microsoft Office applications. ## Description We are seeking a Quality Systems Engineer to support and maintain the Quality Management System (QMS) in a regulated manufacturing environment. The ideal candidate will ensure compliance with applicable regulatory requirements, support quality system processes, lead continuous improvement initiatives, and collaborate with cross-functional teams to maintain product quality and regulatory compliance. Experience in medical devices, pharmaceuticals, biotechnology, or other regulated industries is highly preferred. Roles & Responsibilities: * Maintain and improve the Quality Management System (QMS) in compliance with applicable regulatory and quality standards. * Support compliance with FDA regulations, ISO 13485, ISO 9001, 21 CFR Part 820/QMSR, GMP, and other applicable standards. * Develop, review, and update Standard Operating Procedures (SOPs), work instructions, and quality documentation. * Manage and support Corrective and Preventive Actions (CAPA), Nonconformance Reports (Client), deviations, and change control activities. * Participate in internal, supplier, customer, and regulatory audits and support audit readiness. * Perform root cause investigations using quality tools such as 5 Whys, Fishbone Diagram, and Failure Mode and Effects Analysis (FMEA). * Analyze quality metrics and identify opportunities for continuous process improvement. * Support supplier quality activities, including supplier qualification, audits, and performance monitoring. * Collaborate with Manufacturing, Engineering, R&D, Regulatory Affairs, Operations, and Supply Chain to resolve quality issues. * Assist with risk management activities in accordance with ISO 14971 (for medical device environments). * Support equipment, process, software, and product validation activities (IQ/OQ/PQ) as required. * Ensure document control processes are followed within the electronic Quality Management System (eQMS). * Prepare quality reports, trending analyses, and management review presentations. * Support new product introduction (NPI) and design transfer activities. * Train employees on quality system procedures and regulatory requirements. ## Related Videos - [Automate everything via NodeJS and Puppeteer](https://www.wearedevelopers.com/videos/322-automate-everything-via-nodejs-and-puppeteer) - [Model Based Systems Engineering in an Agile Product Development Process](https://www.wearedevelopers.com/videos/68-model-based-systems-engineering-in-an-agile-product-development-process) - [Quality Strategy with a side of Swiss Cheese](https://www.wearedevelopers.com/videos/467-quality-strategy-with-a-side-of-swiss-cheese) - [From Doubt to Confidence: How Sentry Uses Verdaccio to Bulletproof SDK Releases](https://www.wearedevelopers.com/videos/739-from-doubt-to-confidence-how-sentry-uses-verdaccio-to-bulletproof-sdk-releases) - [Why LLMs Need Observability and How to Do It](https://www.wearedevelopers.com/videos/2117-why-llms-need-observability-and-how-to-do-it) - [Systems Thinking for Performance: How to Diagnose and Fix Slow Systems without Guessing](https://www.wearedevelopers.com/videos/2103-systems-thinking-for-performance-how-to-diagnose-and-fix-slow-systems-without-guessing) ## Related Articles - [Top Characteristics of a Software Engineer](https://www.wearedevelopers.com/magazine/166-top-characteristics-of-a-software-engineer) - [What is Software Engineering?](https://www.wearedevelopers.com/magazine/289-what-is-software-engineering) - [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development) - [The 12 Best Jobs for Software Engineers](https://www.wearedevelopers.com/magazine/401-the-12-best-jobs-for-software-engineers) - [Technical Documentation For Developers](https://www.wearedevelopers.com/magazine/128-technical-documentation-for-developers) - [From developer to manager – what does it take to become an engineering manager?](https://www.wearedevelopers.com/magazine/42-from-developer-to-manager-what-does-it-take-to-become-an-engineering-manager)