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# 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, 21 CFR Part 820 Quality System Regulation, Performance Monitor
- **Published:** October 31, 2026
- **Apply:** https://www.juju.com/job/15_35290ca4

## 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.