Department. Quality. Location. Gainesville, FL. Description. The QA Validation Engineer provides cross-functional support in validation and verification (V&V) development, planning and execution while maintaining corporate engineering and quality systems best practices, policies and procedures. The Validation Engineer, QA is results oriented and has the knowledge and confidence in the areas of Quality Assurance and V&V. Key Responsibilities. Prov...
Department. Quality. Location. Gainesville, FL. Description. The Senior Manager, Supplier QA leads supplier quality initiatives in alignment with ISO 13485 and 21 CFR Part 820, ensuring the compliance and performance of externally sourced materials, components, and services. This role collaborates with internal stakeholders to support supplier selection, qualification, auditing, and ongoing monitoring, while serving as a key liaison to drive supp...
Department. Quality. Location. Gainesville, FL. Description. A Supplier Quality Engineer works with internal customers in support of supplier selection, approval, auditing, and monitoring. Also serves as liaison between suppliers and internal customers to drive supplier quality improvement. Provides technical support for activities associated with supplier assessments, change notifications, and supplier corrective actions. Responsible for impleme...
Department. Quality. Location. Gainesville, FL. Description. The Design Quality Engineer shall provide support to new product development projects. Serve as a subject matter expert on the requirements and processes for product lifecycle management. Key Responsibilities. Ensures that product development projects and changes to current products are conducted in compliance with the FDA Quality System Regulation Design Phases and within Exactech Qual...
Department. Quality. Location. Gainesville, FL. Description. A Supplier Quality Engineer works with internal customers in support of supplier selection, approval, auditing, and monitoring. Also serves as liaison between suppliers and internal customers to drive supplier quality improvement. Provides technical support for activities associated with supplier assessments, change notifications, and supplier corrective actions. Responsible for impleme...
Department. Quality. Location. Gainesville, FL. Description. The Design Quality Engineer shall provide support to new product development projects. Serve as a subject matter expert on the requirements and processes for product lifecycle management. Key Responsibilities. Ensures that product development projects and changes to current products are conducted in compliance with the FDA Quality System Regulation Design Phases and within Exactech Qual...
Department. Quality. Location. Gainesville, FL. Description. The Post-Market Clinical Specialist plays a critical role in ensuring the ongoing safety and performance of medical devices after they enter the market. This position involves clinical evaluation concerning complaint and adverse events and involves collaboration with cross-functional teams to maintain regulatory compliance and improve patient outcomes. Key Responsibilities. Supports the...
Department. AST. Location. Gainesville, FL. Description. The research scientist is responsible for conducting rigorous and reproducible AI/ML activities to support the development of machine learning-based features and software in orthopaedic medical devices. This includes collaborative research initiatives, development and validation of algorithms, and contributions to regulatory documentation and product development. Key Responsibilities. Colla...
Department. Logistics. Location. Gainesville, FL. Description. The Continuous Improvement Engineer will be responsible for developing and sustaining performance management systems, lean manufacturing practices, and continuous improvement initiatives across operations, fulfillment, and other departments as needed. This role will focus on optimizing workflow, improving material and information flow, and implementing standardized work at all levels....
Department. Manufacturing. Location. Gainesville, FL. Description. Manufacture implants and instruments at an introductory level. Key Responsibilities. Operate CNC machines with minimal assistance. Work from written instructions. (Work Instructions). Be able to adjust offsets to maintain dimensional integrity. Ability to inspect own work with minimal assistance. Meet production standards and quality expectations. Ability to document results accur...
Department. Regulatory. Location. US (Remote). Description. The purpose of the Senior Regulatory Specialist is to provide services to fulfill the regulatory requirements necessary to achieve global regulatory approvals / clearances and maintain overall regulatory compliance for the company. Key Responsibilities. With minimal oversight, preparing and maintaining pre-market submissions or post-market change submissions for a variety of markets. Wit...
Department. Custodial & Facilities. Location. Gainesville, FL. Description. Under direct supervision be able to support and maintain Manufacturing Equipment and ancillary support equipment. This includes but is not limited to. Working closely with Technical Service Leadership, Manufacturing Engineer, Machinists, Manufacturing/Quality personnel and Maintenance Mechanics to conduct and document daily, weekly, monthly and annual preventive maintenan...
