Quality Systems Engineer I (Hybrid)

Role: Quality System Specialist responsible for overseeing and maintaining the company's Quality Management System (QMS) to ensure compliance with regulations and standards. Responsibilities include supporting internal and external audits, managing CAPA and nonconformance processes, and driving continuous quality improvements. Key tasks involve document control, change management, data analysis for KPIs, and supporting regulatory compliance activities. Qualifications: Bachelor's degree in a scientific or technical field; 1+ year experience in quality assurance or engineering; ASQ certifications (CQA/CQE/LSS) preferred; proficiency with electronic QMS and QA tools; strong analytical, problem-solving, and communication skills. HighValue: Focus on GxP compliance, ISO standards, and Good Manufacturing Practices; experience with medical device manufacturing; supporting audit readiness and CAPA effectiveness; familiarity with quality documentation and regulatory standards. WorkSetup: Not specified, but implied to be an office-based role supporting company-wide quality activities.