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Results Found: 22
2320 NW 66th Ct.
Gainesville, FL 32653
Sr. Product Development Engineer, Hip & Knee
Category:
Job DetailsDescription   The Sr Product Development Engineer will generally assist in leading a cross-functional project team (including both internal and external team members such as orthopedic surgeons) of several new development projects. 1. Lead a cross-functional project team (including both internal and external team members such as orthopedic surgeons) of several new development projects. 2. Identify and assist with selection of clinical evaluators and design surgeons 3. Obtain feedback from ...read more
Contact:
Phone:(352) 377-1140
2320 NW 66th Ct.
Gainesville, FL 32653
Calibration Technician
Category:
Job DetailsDescription Duties and Responsibilities (Key Deliverables):Coordinates internal and external (vendor) calibration of equipment.Develops, establishes, and maintains written calibration procedures.Performs equipment calibration and repairs according to approved written procedures.Maintains paper-based and electronic calibration records.Works with cross-functional department personnel to support quality and business objectives.Establishes and maintains calibration laboratory to meet 5S requirements ...read more
Contact:
Phone:(352) 377-1140
2320 NW 66th Ct.
Gainesville, FL 32653
Clinical Research Associate
Category:
Job DetailsDescription The purpose of the Clinical Research Associate position is to be responsible for oversight of assigned clinical research projects to ensure high quality data is obtained to support regulatory and marketing needs. This position takes a support or lead role in site initiation and interim monitoring, periodic reporting of study results, and other related activities. The documentation maintained by this position is critical in supporting successful inspections/audits of Exactech’s ...read more
Contact:
Phone:(352) 377-1140
2320 NW 66th Ct.
Gainesville, FL 32653
CMM Applications Specialist
Category:
Job DetailsDescription Duties and Responsibilities (Key Deliverables): 1. Develop & maintain all CMM programs. 2. Facilitate regular CMM maintenance and calibration activities. 3. Develop & maintain inspection program revision control procedures & database. 4. Provide CMM training to inspection and machining personnel. 5. Develop operator efficiencies related to inspection program execution. 6. Generate IRRS’s for products received from suppliers and in house manufacturing. 7. Know and apply the ...read more
Contact:
Phone:(352) 377-1140
2320 NW 66th Ct.
Gainesville, FL 32653
CNC Machinist (2nd Shift)
Category:
Description Manufacture implants and instruments at an introductory level. The CNC Machinist position will be responsible to manufacture implants and instruments at an introductory level. 1. Setup and operate jobs with minimal assistance. 2. Typical types of work, but not limited to: Level 1 Products 3. Work from written instructions; (Work Instructions) 4. Be able to adjust offsets to maintain dimensional integrity. 5. Ability to inspect own work with minimal assistance. 6. Meet production ...read more
Contact:
Phone:(352) 377-1140
2320 NW 66th Ct.
Gainesville, FL 32653
Customer Service Rep.
Category:
Job DetailsDescription Duties and Responsibilities (Key Deliverables): 1. Partner with independent agencies located within a predetermined geographical area focusing on the intersection between ongoing operations, account/support issues while concentrating on the timely closure of any size of service request. 2. Optimize fill rate for assigned accounts. a) Receive, evaluate, verify and process consignment, direct sales, and loaner orders. b) Validate all orders for accuracy and highlight potential ...read more
Contact:
Phone:(352) 377-1140
2320 NW 66th Ct.
Gainesville, FL 32653
Director Marketing, Foot & Ankle
Category:
Job DetailsDescription The Exactech Product Marketing Team exists to drive products to market and empower the sales organization to achieve company sales goals. We do this by understanding our customers’ needs through direct interaction and market analysis, actively and accurately conveying those needs into product definition and development in collaboration with E&D, creating and communicating powerful product messages to our customers and provide effective training on our products. We also manage ...read more
Contact:
Phone:(352) 377-1140
2320 NW 66th Ct.
Gainesville, FL 32653
Model Maker
Category:
Job DetailsDescription   Duties and Responsibilities (Key Deliverables):Work closely with Engineers and Designers to produce the production, assembly, and final finishing of prototypes, models, test specimens, test fixtures, custom implants and special instruments and ensure they are completed in a timely manner.Independently perform machining, assembly, and final finishing operations as instructed by Engineers and Designers.Program, setup and operate CNC and manual equipment.Build tooling and fixtures ...read more
Contact:
Phone:(352) 377-1140
2320 NW 66th Ct.
Gainesville, FL 32653
Packaging Technician (2nd Shift)
Category:
Job DetailsDescription The Packaging Technician will be responsible to assist the Supervisor Packaging in supporting company objectives to meet or exceed the needs of our internal and external customers by meeting production goals and ensuring that all quality, compliance, and safety objectives are met. - This person will support other packaging employees in managing resources responsibly, efficiently, and safely. 1. Understand and follow all SOP’s for the Packaging Area. All product or process ...read more
Contact:
Phone:(352) 377-1140
2320 NW 66th Ct.
Gainesville, FL 32653
Quality Control Technician (Contract Assignment)
Category:
Job DetailsDescription 1. Perform and document inspection requirements following approved SOPs for incoming, in process, OEM and finished products. Document and notify QC Manager of non-conformances. 2. Perform and document inspection requirements following approved SOPs for tissue and tissue related products. Document and notify QC Manager and/or Tissue Bank Director of non-conformances. 3. Responsible for maintaining the security and identity of all tissue related products while under his or her ...read more
Contact:
Phone:(352) 377-1140
2320 NW 66th Ct.
Gainesville, FL 32653
Quality Engineer
Category:
ob DetailsDescription Duties and Responsibilities (Key Deliverables):Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards requirements for worldwide distributionParticipates in E&D design control processes related to design inputs and defines product/process inspection requirements for all current and new products. Develops Quality plans to include inspection drawings and specifications. ...read more
Contact:
Phone:(352) 377-1140
2320 NW 66th Ct.
Gainesville, FL 32653
Regulatory Affairs Specialist, Labeling
Category:
Job DetailsDescription Purpose: This office position is responsible for leading medical device labeling projects (including, but not limited to product labels, IFUs, translations, labeling systems, and UDI initiatives) as necessary to market Exactech Inc. products. It requires demonstrated leadership and communication skills, as well as a broad understanding of label and IFU development, change management systems/procedures/concepts, and labeling systems. Duties and Responsibilities (Key ...read more
Contact:
Phone:(352) 377-1140
2320 NW 66th Ct.
Gainesville, FL 32653
Regulatory Associate
Category:
Job DetailsDescription The purpose of the Regulatory Associate is to provide services to fulfill the regulatory requirements necessary to achieve global regulatory approvals / clearances and maintain overall regulatory compliance for the company. 1. Assist in preparing and maintaining FDA pre-market submissions, Canadian device license applications and international product registrations for medical devices. 2. Assist in preparing and submitting MDD Class III Design Dossiers for review by the Notified ...read more
Contact:
Phone:(352) 377-1140
2320 NW 66th Ct.
Gainesville, FL 32653
Shipping & Receiving Tech (2nd Shift)
Category:
Description 1. Process the shipment of orders for domestic customers, including, but not limited to implants, instruments, biologics, samples, promotional materials, and test products. 2. Perform receipt of inventory functions, including, but not limited to sterile lot, returns, raw materials, manufacturing materials, and dock-to-stock products. 3. Understand and follow all departmental SOPs including SOPs related to tissue and tissue related products as appropriate. Document and report any process ...read more
Contact:
Phone:(352) 377-1140
2320 NW 66th Ct.
Gainesville, FL 32653
Sr CAPA Specialist
Category:
Job DetailsDescription   Duties and Responsibilities (Key Deliverables): Develop and coordinate the company’s Corrective and Preventive Action (CAPA) process to ensure regulatory compliance and effectiveness. • Define and document CAPA requirements and design forms to include required elements to ensure successful BSI and FDA audits/investigations. • Collaborate with Quality Project Team Leaders on suggestions and planned changes to the CAPA process. • Train new CAPA Project Team Leaders. • Assess ...read more
Contact:
Phone:(352) 377-1140
2320 NW 66th Ct.
Gainesville, FL 32653
Sr Design Quality Engineer
Category:
Job Details Description   Duties and Responsibilities (Key Deliverables):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 Quality Management System.Participates in cross-functional teams to review requirements to develop product requirements that support the marketing needs.Participates in cross-functional team to develop risk managements files (plans, assessments and ...read more
Contact:
Phone:(352) 377-1140
2320 NW 66th Ct.
Gainesville, FL 32653
Sr Medical Writer - REMOTE
Category:
Job DetailsDescription Purpose: The purpose of the Senior Medical Writer is to provide medical writing and scientific services to fulfill the regulatory requirements necessary to achieve global regulatory approvals / clearances and maintain overall regulatory compliance for the company.   Duties and Responsibilities (Key Deliverables): 1. Prepare clinical evaluation reports for submission to regulatory bodies to support new product registrations or continuing registrations. 2. Assist Regulatory Affairs ...read more
Contact:
Phone:(352) 377-1140
2320 NW 66th Ct.
Gainesville, FL 32653
Sr. Engineer QA Validation
Category:
Job DetailsDescription Duties and Responsibilities (Key Deliverables): 1. Provide focused, technical, hands-on engineering assistance regarding V&V requirements of medical device processes, materials, equipment and methods including project management, process design, document generation (IQ, OQ, PQ, SOPs, WIs and ETSs), critical process parameter development, protocol execution and summary reports. 2. Executes activities related to the compliance of the sterility assurance program (e.g. ...read more
Contact:
Phone:(352) 377-1140
2320 NW 66th Ct.
Gainesville, FL 32653
Sr. Supplier Quality Engineer
Category:
Job DetailsDescription Duties and Responsibilities (Key Deliverables): 1. Knowledgeable in FDA 21CFR Part 820 regulations and ISO-13485. 2. Must adequately represent Exactech and Exactech QA processes while helping to build Exactech-supplier cross functional partnerships. 3. Assumes an active role by facilitating selection, development, qualification, approval and monitoring of suppliers 4. Leads as supplier liaison with internal customers to ensure effective problem resolution of supplier quality ...read more
Contact:
Phone:(352) 377-1140
2320 NW 66th Ct.
Gainesville, FL 32653
Supplier Quality Engineer
Category:
Job Detail Description   Duties and Responsibilities (Key Deliverables): 1. Knowledgeable in FDA 21CFR Part 820 regulations and ISO-13485. 2. Must adequately represent Exactech and Exactech QA processes while helping to build Exactech-supplier cross functional partnerships. 3. Assumes an active role by facilitating selection, development, qualification, approval and monitoring of suppliers 4. Leads as supplier liaison with internal customers to ensure effective problem resolution of supplier quality ...read more
Contact:
Phone:(352) 377-1140
2320 NW 66th Ct.
Gainesville, FL 32653
Sustaining Engineer
Category:
Job DetailsDescription Purpose: Provide design, engineering, and analysis support to other engineers and designers in the maintenance of orthopedic implants and instruments currently on the market.Duties and Responsibilities (Key Deliverables): 1. Provide design, engineering, and analysis support to other engineers and designers in the maintenance of orthopedic implants and instruments currently on the market as part of continuous improvement. 2. Apply sound engineering problem-solving techniques to ...read more
Contact:
Phone:(352) 377-1140
2320 NW 66th Ct.
Gainesville, FL 32653
Test Lab Technician
Category:
Job DetailsDescription Duties and Responsibilities (Key Deliverables): 1. Work closely with engineering staff to perform testing as outlined by protocols or other instructions. 2. Create test set-ups to execute testing. 3. Record test data to support engineering documentation. 4. Perform basic maintenance as needed to testing equipment. 5. Understand and follow all SOP’s required for position. 6. Understand and comply with all department safety policies and procedures. 7. Organize and prioritize ...read more
Contact:
Phone:(352) 377-1140