Exactech

QA Engineer

• 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

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

• 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

• 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

• 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

Supplier Quality 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.

QA Validation Engineer

Supply Planning Analyst

Senior Manager, Supplier QA

QA Post-Market Engineer

Supplier Quality Engineer

Design Quality Engineer