Exactech

Graphics Designer

• Provide Creative Services to support Exactech’s sales, marketing and corporate communication goals.
• Provides design support for all digital communications tools in accordance with and in support of corporate global brand standards.
• Collaborates with Senior Digital Designer and Web Team in the implementation of storyboards and designs relating to all digital media, including but not limited to global websites, video editing, and digital employee communication vehicles.
• Performs updates to existing digital communication vehicles.
• Promotes and supports a team-based approach to the development and execution of digital media.
• Know and apply the Quality System and any appropriate Federal and International Standards.
• Assists and support other employees, teams and sales personnel as necessary.
• Reports to Sr. Creative Director.

Digital Designer

QA Engineer

• Lead and manage the global process for supplier requirements, selection, qualification, approval, and ongoing monitoring in compliance with medical device regulations
• Establish and maintain criteria for supplier audit schedules; lead audits (on-site, virtual, or documentation-based) to ensure supplier compliance
• Review and approve Supplier Corrective Action Reports (SCARs), evaluating effectiveness and closure
• Assess resource needs and allocate appropriately to meet internal and external customer requirements
• Promote effective cross-functional collaboration with Development, Procurement Engineering, Purchasing, and other business units
• Develop, implement, and track quarterly and annual quality goals and objectives aligned with organizational priorities
• Ensure compliance with departmental safety policies and maintain a safe working environment
• Participate in design transfer activities, providing supplier quality input during product development and launch
• Lead or contribute to continuous improvement initiatives focused on enhancing supplier quality performance
• Analyze supplier non-conformance trends, support investigations, and collaborate on corrective actions and inspection/test procedures
• Partner with Purchasing and QA to monitor and improve supplier performance metrics
• Support the development and negotiation of Quality Agreements and supplier Terms & Conditions
• Lead justification and approval of supplier-driven change requests, including process and product deviations
• Apply and uphold the Quality System and relevant domestic and international standards applicable to medical device manufacturing
• Mentor and develop the Supplier Quality team, fostering collaboration, growth, and continuous improvement

Senior Manager, Supplier QA

Analyst

• Coordinate the right products to be in the right place, at the right time, and in the right quantity.
• Work closely with cross functional teams to develop supply plans, close supply gaps, and communicate supply health, risks, and actions to support customer demand and achieve internal business objectives.
• Generate, maintain, and communicate production plans in one or more supply areas to meet target customer service levels and financial goals.
• Set achievable delivery expectations with internal partners for product launches, supply gap recovery, and other production/procurement targets.
• Analyze, monitor, and flag capacity concerns with operations leadership and make recommendations.
• Identify problems associated with established production plans and resolve them by collaborating with Planning and Purchasing.
• Utilize analytical tools and methodologies (scenario models, simulation, programming, decision support systems) to identify delivery gaps, improve supply plans, reduce cost, and improve asset utilization.
• Communicate complex supply plans and analyses concisely and accurately with internal partners and leaders to facilitate decisions.
• Complete ad hoc supply reviews and inventory removal requests; prep and analyze data for cross-functional meetings.
• Lead meetings to review backorders, supply health, production plans, and related topics.
• Utilize ERP (QAD) and other systems/tools to drive MRP planned orders toward meeting business objectives (delivery, inventory, cost).
• Support process improvement projects in respective supply focus area to enhance existing processes and systems.
• Reports to Supply Planning Manager.

Supply Planning Analyst

• Provides verification and validation expertise through IQ, OQ, and PQ protocol development and execution utilizing approved product and process validation SOP.
• Develop validation and verification plans and protocols for new product manufacturing (internally and externally) and related inspections.
• Participate in the validation of corporate software packages ensuring adherence to industry requirements.
• Execute activities related to the compliance of the sterility assurance program (e.g. Biocompatibility/Endotoxin testing, environmental monitoring, and quarterly dose audits).
• Execute activities related to the Exactech Analytical Laboratory (Analytical testing and reporting, equipment qualification, equipment preventive maintenance and equipment calibration).
• Prepare documentation and execute V&V activities utilizing a risk-based approach (pFMEA, FMEA, etc.) and Good Engineering Practices (GEPs) ensuring compliance to medical device industry regulations.
• Coordinate personnel training, protocol and process documentation/record retrieval supporting timely execution and closure of corporate V&V activities.
• Maintain corporate validation process auditing program ensuring timely completion of auditing activities.
• Work closely with QA management to maintain V&V planning (Validation Project Dashboard) documenting progress towards completion of corporate V&V initiatives.
• Participate in identification, maintenance, development and enhancement of corporate systems, processes and standards.
• Assist in identifying, analyzing and correcting internal and external manufacturing deviations, QE MRB related issues and anomalies related to V&V activities.
• Contribute to cross-functional project teams in device cleanliness and manufacturing V&V work such as material testing, specification development, process capability studies, research, investigation and process/test documentation.
• Participate in company-wide QE and validation related Corrective and Preventive Actions resulting from internal/external non-conformances, recalls and/or field actions.
• Participate in third party, customer and regulatory audits as required.
• Participate in E&D design control processes related to design inputs and define product/process inspection requirements for all current and new products.
• Analyze, justify, and recommend purchase of in house or vendor supplied inspection equipment.
• Responsible for QE related DCR product and process change review and approval.
• Know and apply the Quality System and appropriate Federal and International standards.
• Assist and support other employees, teams, and sales personnel and performs other tasks as necessary.

QA Validation Engineer

• Performs complaint product analysis and root cause investigation in support of Exactech and regulatory requirements, product improvement, and issue escalation.
• Applies sound engineering problem-solving techniques during complaint investigation activities.
• Performs complaint product analysis and testing per Exactech's procedures and requirements.
• Performs complaint root cause analysis.
• Performs complaint risk analysis and complaint history reviews.
• Escalates complaint investigation findings, as appropriate and per Exactech's procedures and requirements.
• Collaborates with cross-functional engineering teams to ensure thorough investigations and appropriate escalations.
• Documents all complaint investigation and escalation activities per Exactech's procedures and requirements.
• Provides design, engineering, and analysis support to other engineers and designers in maintenance of orthopedic implants and instruments as part of continuous improvement.
• Supports CAPAs, HHEs, NCRs, and other quality processes, as needed.
• Supports completion of complaint activities in line with department metrics and KPIs.
• Supports audits and audit requests for complaints.
• Drafts investigation responses to customers, as requested.
• Supports drafting and revision of procedures, work instructions, forms, technical documents, and protocols.
• Supports continuous improvement activities and assists in training complaint team members.
• Know and apply Exactech’s Quality System and appropriate FDA and international standards.
• Assist and support other employees, teams, and sales personnel as necessary.

QA Post-Market Engineer

• Provide support to new product development projects and serve as a subject matter expert on product lifecycle management requirements and processes.
• Ensure product development projects and product changes comply with FDA Quality System Regulation Design Phases and Exactech Quality Management System.
• Participate in cross-functional teams to review and develop product requirements supporting marketing needs through the product life cycle.
• Aid transfer of design requirements to manufacturing (Exactech Manufacturing or suppliers) as part of New Product Development.
• Aid insourcing of new and previously released products to Exactech Manufacturing.
• Aid transfer of design requirements for additional suppliers for previously released products.
• Aid development and release of Design Control Documentation (Design Transfer Matrices, Design Verification & Validation, etc.).
• Aid development and execution of manufacturing process verifications and validations.
• Participate in cross-functional teams to develop risk management files (plans, assessments, and reports).
• Review new and modified product designs for quality characteristics and develop quality inspection plans.
• Provide quality support to facilitate resolution of product nonconformities.
• Lead and/or participate in company-wide Corrective and Preventive Actions projects.
• Assist in inspection, investigation, and documentation of product customer complaints.
• Responsible for product and process change review and approval.
• Direct or assist inspection training for QC inspectors and QE technicians.
• Know and apply the Quality System and any appropriate Federal and International standards.
• Assist and support other team members as necessary.

Design Quality Engineer

• Works with internal customers in support of supplier selection, approval, auditing, and monitoring
• Serves as liaison between suppliers and internal customers to drive supplier quality improvement
• Provides technical support for supplier assessments, change notifications, and supplier corrective actions
• Implements quality-related programs and projects
• Facilitates selection, development, qualification, approval and monitoring of suppliers
• Leads supplier audits, supplier visits, and coordinates / leads supplier conference calls
• Leads or participates in development or continuous improvement projects focused on supplier quality
• Identifies supplier non-conformance (NPR) trends and provides technical support on NPR investigations
• Works cross-functionally to establish inspection and test procedures and tracks supplier quality performance with Purchasing and QA
• Establishes Quality Agreements and Exactech-Supplier Terms & Conditions with suppliers
• Leads justification for supplier-based Deviation Requests and is actively involved in Supplier CAPAs
• Participates in First Article Inspection (FAI) program and supports IQ, OQ, PQ protocol development and execution
• Develops metrics, reports, and management review presentations as needed
• Assists and supports other team members as necessary