Quality Systems Engineer, Senior Advita Ortho Gainesville, FL Job Details Full-time 1 day ago Qualifications Technical engineering Quality management standards in production Accreditation standards (regulatory compliance area) Software implementation Technical solutions implementation Leading team collaboration initiatives Biomedical regulatory compliance Project leadership Cross-functional team management Cross-functional communication Full Job Description 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.

Key Responsibilities 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.

Skills Knowledge and Expertise Education:

Bachelor's Degree in Engineering or related science from an accredited institution required; Master's Degree preferred.

Experience:

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. About Advita Ortho