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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Quality Systems Engineer, Senior - **Company:** Advita Ortho - **Location:** Gainesville, FL, United States - **Experience:** Expert - **Contract:** Internship / Graduate position - **Skills:** Data Analysis, Learning Management Systems, Document Management Systems, Power BI, Verification and Validation (Software), System Testing, Data Processing, Data Management, Mdsap, Teamcenter (Software) - **Published:** August 5, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=ce6b607c84870f0c ## About the Role * Bachelor's Degree in Engineering or related science from an accredited institution required; Master's Degree preferred., * Minimum of 6 years full-time medical device engineering/quality/regulatory technical experience. This experience shall be in addition to any college internships. Relevant experience in other areas may be considered. * Experience in Change Management documentation systems preferred. * Experience in electronic Quality Management Systems solutions (e.g. SmartSolve IQVIA, Cornerstone, Teamcenter). * Experience in data management and reporting utilizing PowerBI. * Professional Certification through the American Society for Quality (ASQ) or equivalent in Auditing for Medical Devices. * Experience in software validation, operating within a Quality Management System Functional/Technical Knowledge, Skills and Abilities Required: * Demonstrated ability to lead cross-functional teams and project * Demonstrated ability to communicate effectively quality related discussions * Experience with the development, implementation, and maintenance of electronic solutions for Quality Management Systems elements such as: CAPA, Audits, Data Analysis, etc. * Demonstrable knowledge of all domestic and international Quality System regulations. ## Description The Quality Systems Engineer, Senior is a top-level leader, developing and supporting the company's Quality Management Systems, ensuring adherence to domestic and international regulations and company policies., * Quality Systems and Regulatory Compliance: + Know and apply the Quality System and any appropriate Federal and International standards (FDA, ISO 13485, MDSAP, EU MDR, etc.) + Provide leadership and strategy for the team in the overall administration and maintenance of the QMS processes, ensuring alignment with organizational goals. + Ensure that Quality Management Systems documentation meets the required guidelines for maintaining FDA compliance and ISO/EC/MDR certification. + Support the strategic initiatives of the company to achieve and maintain regulatory compliance. * Corrective and Preventive Action: + Oversees CAPA system, including maintenance, development and system validation. + Develops and facilitates continuous training and development for the CAPA process, including root cause analysis and verification of effectiveness. + Responsible for the reporting of CAPA system KPIs during Quality Systems Governance and Management Review. + Operates as lead Subject Matter Expert during internal/external audits and inspections.. * Product/Process Nonconformance: + Oversees NC system, including maintenance, development and system validation. + Supports cross-functional teams with investigations, root cause analysis, escalation decisions, and dispositions. + Operates as lead Subject Matter Expert during internal/external audits and inspections. * Product Corrections and Removals: + Oversees the process for product event escalations, health hazard evaluation, and execution of product corrections and removals. + Provides guidance and drives cross-functional collaboration to make timely decisions, based upon product risk. + Supports cross-functional teams with investigations, root cause analysis, escalation decisions, and final decisions. + Operates as lead Subject Matter Expert during internal/external audits and inspections. * Training and Cross-Functional Responsibilities: + Oversees the Learning Management Solution (LMS), including maintenance, development and system validation. + Develop training and competency solutions to meet the needs of the company and its Quality Management System. + Monitors Quality Systems training curricula for completeness, appropriateness and execution. + Responsible for the reporting of LMS system KPIs during Quality Systems Governance and Management Review. + Operates as lead Subject Matter Expert during internal/external audits and inspections. * Data Analytics & Reporting Responsibilities: + Assist with the development of training materials and documentation to ensure effective dissemination of knowledge to team members and stakeholders. + Responsible for compiling process data for presentation during Quality Systems Governance and Management Reviews. + Facilitates Quality Systems Governance and Management Review meetings in accordance with company procedures. ## Related Videos - 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