Exactech

QA 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

• 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 Post-Market Engineer

Supplier Quality Engineer

Design Quality Engineer