RA Project Manager, EU MDR

Exactech, Inc.
Gainesville, FL
Purpose:

The EU MDR RA Project Manager will lead Exactech's EU MDR Portfolio Compliance project. The EU MDR RA PM will provide oversight of direction to the cross-functional team developing technical documentation for compliance with EU MDR.

Duties and Responsibilities (Key Deliverables):

1. Develop, plan, communicate, maintain and execute overall MDR project plan.

2. Create, monitor and analyze project risks and identify mitigation strategies.

3. Maintain project governance; provide regular updates & report-outs to Exactech's MDR Project Leadership Board.

4. Partner with MDR workstream leads and teams to define workstream deliverables, timelines and milestones.

5. Collaborate with project team, business units, and workstream leads, as well as functional leaders to ensure efficient execution of project strategy. Identify, escalate, and facilitate resolution of project challenges and/or delays.

6. Maintain and provide oversight for timely execution of Exactech's MDR Quality Management Plan.

7. Support the development of business processes and procedures for compliance with EU MDR

8. Support the submission development and review process with Exactech's Notified Body.

a. Facilitate regular MDR update calls with Exactech's Notified Body

9. Develop and maintain cross-functional EU MDR budget, monitor spend to budget, and provide regular reports to the MDR Project Leadership Board.

10. Develop Organizational EU MDR awareness and expertise by identifying and coordinating training.

11. Partner with other project leaders to ensure coordination of activities and timelines.

12. Partner with Regulatory and Quality Operations as well as IT project management to develop systems and IT tools requirements to support effective standard processes.

13. Facilitate regularly scheduled meetings, take meeting minutes with action items, and follow up with SMEs on deliverables.

14. Know and apply the Quality System and any appropriate Federal and International standards.

Job Requirements:

Education: A minimum of a bachelor's degree from an accredited institution, preferably in physical or life sciences; Master's Degree preferred

Experience & Qualifications: • Minimum 7 years' experience in medical device industry in regulatory affairs, project management or related field, orthopaedic device industry experience preferred.

* Working knowledge of EU MDR, with basic knowledge of global regulatory affairs
* Project Management experience in the medical device industry preferred
* Demonstrated experience leading in-depth technical and strategic discussions with Health Authorities
* Demonstrated ability to influence and negotiate with cross-functional partners and stakeholders, both internal and external

Functional/Technical Knowledge, Skills and Abilities Required: • Proficiency with Microsoft office productivity tools

* Proficiency with Project Management tools

INTERN - Graphic Design

Exactech, Inc.
Gainesville, FL
Projects/Responsibilities:

* The primary role of this intern will be to assist with small print design projects for Sales & Marketing, Training and Employee Communications.

Required Skills:

* Excellent writing and editing skills

* Ability to manage multiple projects and work independently.

* Proficiency with Adobe Suite, especially InDesign

Educational Requirements:

Interns must be currently enrolled and in their Junior or Senior year of either their bachelors or graduate program.

Systems Administrator

Exactech, Inc.
Gainesville, FL
Purpose:

The System Administrator's role is to manage and tune in-house computer software systems and network connections to ensure high levels of availability and security of the supported business applications. This individual also participates in the planning and implementation of policies and procedures to ensure system provisioning and maintenance that is consistent with company goals, industry best practices, and regulatory requirements.

Duties and Responsibilities (Key Deliverables):

1. Participate in and support capacity planning and the development of long-term strategic goals for systems and software in conjunction with end-users and department managers.

2. Coordinate with network engineering, business application, and database administration functions to implement and support enterprise systems that utilize industry best practices to meet corporate objectives.

3. Utilize enterprise monitoring and management tools such as SolarWinds and Intune to administer systems and devices.

4. Manage all operating systems and end-user software.

5. Manage communications (email, collaboration platforms, etc.) and connection solutions, including server connectivity, local area networks, intranet, and internet applications.

6. Ensure the integrity and security of enterprise data on host computers, multiple databases, and during data transfer in accordance with business needs and industry best-practices regarding privacy, security, and regulatory compliance.

7. Support e-discover and document retention activities resulting from legal holds or regulatory compliance.

8. Manage end user accounts, permissions, access rights, and storage allocations in accordance with best practices regarding privacy, security, and regulatory compliance.

9. Perform platform performance and security audits.

10. Perform and test routine system backups and restores.

11. Anticipate, mitigate, identify, troubleshoot, and resolve hardware and software problems on servers, input/output fleet, and workstations. Escalate incidents as necessary.

12. Practice network asset management, including maintenance of network component inventory and related documentation and technical specifications information.

13. Support application development teams throughout project lifecycles.

14. Analyze system, server, application, network, and input/output device performance against established KPI's.

15. Recommend, schedule, and perform software and hardware improvements, upgrades, patches, reconfigurations, and/or purchases.

16. Conduct research on emerging products, services, protocols, and standards in support of systems software procurement and development efforts.

17. Create required reports in response to business user needs.

18. Develop, document, and maintain policies, procedures and associated training plans for system administration and appropriate use.

19. Document work and changes in the ITSM platform in accordance with operating and change management procedures.

Job Requirements:

Education:

Bachelor's Degree in a related field from an accredited institution required.

Experience:

* 5+ years' experience in implementation of server, storage, and desktop environments. Microsoft OS required. Linux also preferred.
* 2 years' experience with cloud-based platforms preferably (AZURE). AWS is a bonus.
* Solid Knowledge of M365 administration
* Working technical knowledge of network, PC, and server operating systems.
* Extensive application support experience with Microsoft products.
* Experience working with virtualization platforms (VMWare and Cisco UCS)
* Strong knowledge of backup and recovery platforms preferably Commvault
* Working technical knowledge of current systems software, protocols, and standards, including User Access Management (OKTA), Active Directory, SCCM, etc.
* Experience using scripting tools (PowerShell) to automate processes.
* Hands-on software and hardware troubleshooting experience.
* Experience with data management.
* Experience documenting and maintaining configuration and process information.
* Good understanding of the organization's goals and objectives.
* Knowledge of applicable data privacy practices and laws.
* Familiarity with ITIL foundation standards.

Functional/Technical Knowledge, Skills and Abilities Required:

* Excellent analytical, mathematical, and creative problem-solving skills.
* Excellent written, listening, interpersonal, written, and oral communication skills.
* Strong teamwork and interpersonal skills and ability to communicate with all management levels.
* Logical and efficient.
* Keen attention to detail.
* Ability to conduct research into systems issues and products as required.
* Ability to communicate ideas in both technical and user-friendly language.
* Highly self-motivated and directed.
* Ability to effectively prioritize and execute tasks in a high-pressure environment.
* Strong customer service orientation.
* Experience working in a team-oriented, collaborative environment.
* Exceptional ability to lead change using positive and collaborative methods.
* Skilled at conflict resolution and problem-solving to achieve win-win outcomes.
* Able to communicate technical or complex subject matter in business terms.
* Excellent execution skills. Ability to achieve and measure results and progress.
* Ability to effectively build relationships with key business stakeholders and IT staff through positive interaction and problem identification and resolution.

Senior Product Development Engineer

Exactech, Inc.
Gainesville, FL
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 clinicians to develop products.

4. Interact with sales force to assist with training of products in the field.

5. Determine needs assessment for development projects.

6. Maintain and improve existing products and processes.

7. Define and execute product testing and validation protocols.

8. Provide design, engineering, and analysis direction to other engineers and designers in the development and maintenance of orthopedic implants and instruments.

9. Apply sound engineering problem-solving techniques to product development and maintenance tasks including design, analysis, material selection, and inspection requirements and manufacturing process requirements.

10. Prepare and submit written and oral communications that describe product design concepts, attributes and performance and project status. Areas of involvement include customer and sales support, regulatory submissions, Design History Files, device evaluation and testing, manufacturing or supplier support, quality control, packaging, operating room support, device complaint evaluation, patent disclosures and instrument refurbishment.

11. Assure timely and effective project completion according to the project plan and budget.

12. Review engineering designs for feasibility and accuracy.

13. Approve engineering drawings and specifications.

14. Procure and evaluate prototypes.

15. Identify, analyze and recommend new technologies or materials for specific product applications.

16. Assist in patent application preparation, patent review and patent analysis.

17. Support and participate in company and product strategy formulation.

18. Establish, develop and maintain strong working relationships with all necessary personnel to ensure smooth product design, development and commercialization.

19. Establish appropriate project plan (i.e. define tasks, dependencies, schedule and resource requirements).

20. Complete and approve all Design History File documentation for assigned projects as required.

21. Assist in the resolution of manufacturing- or quality-related issues.

22. Perform device evaluations.

23. Participate in the establishment of goals, project plans and resource requirements.

24. Play a key role in setting product strategies.

25. Study and recommend improvements to existing products and processes. This entails staying "up to date" on emerging material and medical product technologies. This may be accomplished by attending seminars, classes & industry meetings.

26. Provide mentorship and professional guidance to junior engineers.

27. Know, apply and teach elements of the Quality System and any appropriate Federal and International standards.

28. Assist, teach and support other employees, teams, and sales personnel as necessary.

Job Requirements:

Education: Bachelor's Degree in Mechanical Engineering, Biomedical Engineering or equivalent from an accredited institution required; Master's Degree preferred

Experience:

* Minimum of 7 years of full-time medical device product development experience. This experience shall be in addition to any college internships. Relevant product development experience in other areas may be considered.
* Must have successfully completed a minimum of one major project and three minor projects (e.g., line extensions, implant or instrument system modifications, etc.) of sufficient complexity. During the execution of these projects, must have been involved in all aspects of the product development process. A minor project involves the modification, adaptation or extension of an existing product or product line.
* Must have a thorough understanding of theoretical technical principles in the following areas: mechanical drafting, geometrical dimensioning and tolerancing, computer aided design, engineering statics and dynamics, mechanics of materials, mechanical engineering design, materials, and technical writing.

Functional/Technical Knowledge, Skills and Abilities Required:

* Must have excellent communication (verbal & written) and organizational skills.
* Must have excellent interpersonal skills and must have demonstrated ability to work effectively in a team environment.
* Must be creative and must have the ability to independently apply theoretical technical principles to product design.
* Must have a practical working knowledge of orthopedics, anatomy and physiology, especially as related to the musculo-skeletal system, fundamentals of orthopedic surgery (major joints), mechanical test and measurement techniques/methods, engineering drawing interpretation, manufacturing and inspection methods/processes, FDA/ISO requirements, project management, orthopedic implants and the materials used in orthopedic implants and instruments.
* Must have the ability to apply parametric solid modeling and drafting conventions to design projects.
* Must have knowledge of various software packages including Microsoft Office applications and CAD applications.
* Must have the ability to prioritize and manage several projects simultaneously.
* Travel up to 20%

Intern - Instructional Design

Exactech, Inc.
Gainesville, FL
Exactech, headquartered in Gainesville, FL, exists to help people improve their quality of life and regain their independence if they've been injured or developed arthritic disease. We do this through innovative ideas, high quality products, education and commitment to service.
Summary of the position

As an Instructional Design Intern, you will support a variety of initiatives for the Learning and Development Team. As our intern, you will work collaboratively with the Learning Technologist, LMS Administrators and key business groups to deliver unparalleled learning experiences for Exactech's employees.

* Develop and Implement prototype project for new Quality Training Process in Cornerstone LMS
* Implement user testing of new processes
* Design and Develop training to support employees using the new training process
* Execute special projects to support LMS Administration
* Implement internal social site to communicate and deliver training
* Create reporting solutions to track LMS projects
* Strong Project Management skills
* Strong computer skills including proficiency with Microsoft products (MS Teams and SharePoint experience), HTML and web-browsers
* Experience with Course authoring Software (such as articulate or Camtasia), LMS experience (ideally as an administrator) and AdobeCC Products is desirable
* Motivated to take initiative and work effectively in teams
* Excellent communication and organizational skills
* Ability to quickly adapt to new work and handle multiple priorities
* Effectively work in an extremely fast-paced, dynamic environment
* Work collaboratively on a diverse team
* Ability to work 30-40 hours per week during summer semester

Juniors/Seniors enrolled in undergraduate degree program in Educational Technology or MED/MAE students enrolled in Educational Technology, or related major preferred

Quality Control Technician

Exactech, Inc.
Gainesville, FL
Purpose:

To ensure all products meet Exactech specifications prior to final acceptance. This includes review and completion of applicable documentation. Additionally, these tasks shall be accomplished in compliance with FDA and ISO Standards as delineated by the Quality Management System.

Duties and Responsibilities (Key Deliverables):

1. Perform and document inspection requirements following approved SOPs and WIs for incoming and finished products including implants, instrumentation, raw material, and trays. Document and notify QC Supervisor / Manager of non-conformances (NC).

2. Perform product inspection in accordance to established Sampling Plans per SOP 701-103-129.

3. Maintain ERP system (QAD) status and location of product to ensure accurate identification and traceability.

4. Perform Stock Audits as assigned by QC Supervisor / Manager.

5. Perform all duties as assigned by QC Supervisor / Manager.

6. As needed - Perform Environmental Monitoring tasks.

7. Maintain and disseminate a positive work atmosphere based on Exactech Values and goals.

8. Perform First Article Inspection (FAI) and/or Special Inspections (SI) per established procedures.

9. Create NC record, segregate NC product, and completion of NC systemic tasks as assigned by QC Supervisor/Manager.

10. Assist with Material Review Board process and execute NC dispositions.

11. Know and apply the Quality System and any appropriate Federal and International standards.

12. Assist and support other employees, teams, and sales personnel as necessary.

Job Requirements:

Education: High School Diploma or GED required.

Experience:

* Prior work in a Quality department in a regulated industry preferred.
* Experience utilizing Geometric Dimensioning and Tolerancing (GD&T) preferred.

Functional/Technical Knowledge, Skills and Abilities Required: • Attention to detail, accuracy, and documentation skills.

* Aptitude to learn the use of basic Quality measurement equipment and tools such as profile overlays, calipers, hand gages, etc.
* Basic computer skills
* Familiar with 21 CFR Part 820 and ISO-13485 subclauses on Acceptance Criteria.
* Entry level understanding of GD&T ASME Y14.5.
* Ability to use Micrometers, Calipers, Depth-gauge, Height gauge, Visual Comparator, and Vision-System.

Intern - Engineer Product Design - Spring Semester

Exactech, Inc.
Gainesville, FL
Exactech, headquartered in Gainesville, FL, exists to help people improve their quality of life and regain their independence if they've been injured or developed arthritic disease. We do this through innovative ideas, high quality products, education and commitment to service.
Duties might include:

* Special instruments
* General design and development projects supporting hip, knee, shoulder or foot & ankle projects
* Testing support

Qualifications

Motivated to take initiative and work effectively in teams

Excellent communication and organizational skills

Ability to quickly adapt to new work and handle multiple priorities

Effectively work in an extremely fast-paced, dynamic environment

Work collaboratively on a diverse team

Ability to maintain confidentiality of employees and company sensitive information

Ability to work 30-40 hours per week during summer semester

Education

Juniors/Seniors enrolled in undergraduate degree program in Mechanical/Biomedical Engineering preferred

Students pursuing an advanced degree in Mechanical/Biomedical Engineering will also be considered

Principal Lifecycle Regulatory Specialist

Exactech, Inc.
Gainesville, FL
Purpose:

The Principal Lifecycle Regulatory Specialist provides regulatory support of the Lifecycle (Postmarket) projects of commercialized products. Accountabilities include activities such as assessment of proposed changes for regulatory impact, regulatory strategy and support for change projects, compliance with Conditions of Approval, EU renewals and regulatory review & approval of advertising and promotion. The Lifecycle Regulatory Specialist will partner with the cross functional team members (e.g., BUs, Operations, etc.) and regulatory colleagues (e.g., the BU, Regional and RO & RCoE RA teams) to develop and execute global regulatory strategies in support of commercialized products.

Duties and Responsibilities (Key Deliverables):

1. Communicate directly with regulatory agencies and health authorities regarding registrations, submissions and regulatory strategies.

2. In partnership with the business and regulatory colleagues (e.g., BU, Operations, and the BU, Regional and RO & RCoE RA teams) develop and execute regulatory strategies and timelines to support proposed changes to commercialized product.

3. Identify and communicate regulatory impact, regulatory requirements and submission deliverables, and execute to achieve regulatory milestones.

4. Provide input to the change teams on project and test plans, ensuring that the plans address all elements of the global regulatory strategy.

5. Maintain awareness of the global regulatory environment; assess and communicate the impact of key environmental changes LC RA initiatives and strategies environment.

6. Review and approve post-launch advertising and promotion (A&P)

7. Oversee compliance with any regulatory Conditions of Approval.

8. Support regulatory audits and inspections

9. Interpret and apply medical device regulations and standards

10. Know and apply the Quality System and any appropriate Federal and International standards.

11. Assist and support other employees, teams, and sales personnel as necessary.

Job Requirements:

Education: Bachelor's Degree in a related field from an accredited institution required; Master's Degree preferred

Experience: • Minimum of 10 years' experience in the medical device industry specifically in Regulatory Affairs.

* Bachelor's Degree in physical or life sciences preferred.
* Orthopaedic device industry experience preferred.
* Experience in US, EU and/or international submissions/registrations required Working knowledge of US, EU and international medical device regulations required
* Demonstrated experience leading in-depth technical and strategic discussions with Health Authorities required
* Demonstrated ability to influence and negotiate with cross-functional partners and stakeholders, both internal and external required
* Regulatory Affairs Certification (RAC) preferred

Functional/Technical Knowledge, Skills and Abilities Required:

* Proficiency with windows-based office productivity tools (Microsoft Office)

IT Solutions Delivery Analyst II

Exactech, Inc.
Gainesville, FL
Purpose:

The Solutions Delivery Analyst's role is to deliver technology infrastructure-based capabilities and solutions to various business and functional units across the enterprise and ensure the stability and integrity of data, voice, video, collaboration, and wireless network services. It is vital that this person possess strong technical skills and is focused on the effective and efficient delivery of solutions that address the needs of the business. This is achieved by planning, designing, and implementing infrastructure and collaboration platforms across the organization.

The Solutions Delivery Analyst will be responsible for developing and implementing end-user training and adoption plans based on the understanding of the user experience modeling and design. This person will participate in installing, configuring, maintaining, supporting, and optimizing all communications services. This person in collaboration with the Network and Communications Analyst will analyze and resolve network and communications related issues in a timely and accurate fashion, and support user needs where required. The Solutions Delivery Analyst will participate with the installation, monitoring, maintenance, support, and optimization of all network hardware, software, and communication links. This individual will work with the Director, Global Infrastructure & Services to define and implement the company's security strategy and associated policies.

The Solutions Delivery Analyst will collaborate with the Director, Global Infrastructure & Services in the integration of Exactech company acquisitions ensuring a global infrastructure and achievement of company SLAs.

This position reports directly to the Director, Global Infrastructure & Services who reports to the CIO.

Duties and Responsibilities (Key Deliverables):

Strategy & Planning

1. Collaborate with Director, Global Infrastructure & Services and Business Stakeholders to define and assess near- and long-term collaboration and network capacity and capabilities needs.

2. Create and maintain documentation as it relates to network, collaboration and business platform configuration, mapping, processes, protocols, standards, and service records.

3. Develop, implement, and maintain a solutions delivery framework that includes policies, procedures, user adoption and training plans for enterprise solutions, usage, and disaster recovery.

4. Collaborate with Information Technology Business Partners to identify opportunities to provide solutions and enhanced capabilities to the enterprise.

5. Implement the company's security strategy and associated policies and procedures.

Acquisition & Deployment

6. Conduct research on enterprise solutions, services, protocols, and standards to remain abreast of developments in the collaboration solutions and services industry.

7. Oversee new and existing solution delivery and user experience modeling frameworks.

8. Interact a with vendors, outsourcers, and contractors to secure products and services.

9. Participate in the deployment of wireless and mobile security countermeasures, including personal firewalls, anti-virus software, encryption, and so on.

10. Design and deploy enterprise-class solutions, including collaboration platforms.

11. Collaborate with the Network and Communications Analyst on the design and deployment of on premise and cloud-based network infrastructure.

Operational Management

12. Execute the deployment of new and enhanced solutions to the enterprise based on the strategic plan and implementation framework.

13. Project management of infrastructure related projects through the full life cycle.

14. Oversee installation, configuration, maintenance, and troubleshooting of end user workstation hardware, software, and peripheral devices related to collaboration solutions.

15. Monitor and test end-to-end solution performance as it relates to the user experience and provide statistics and reports to ensure satisfaction of established SLAs.

16. Participate in managing all network and wireless network security solutions.

17. Conduct periodic platform and solution security audits to ensure compliance with established security standards.

18. Conduct usability assessments to gauge user satisfaction and collect ideas for feature enhancements.

19. Collaborate with 3rd party providers to comply with company operations needs and resolve outages in compliance with established SLAs.

20. Oversee installation, configuration, maintenance, and troubleshooting of end-user mobile hardware, software, and peripheral devices in collaboration with the Service Desk Technicians.

21. Assist as needed with the maintenance of servers, including database, e-mail, print and backup servers and their associated operating systems and software.

22. Assist in the monitoring of network and wireless network performance and troubleshoot problem areas as needed.

23. Manage and/or provide guidance to junior members of the team.

24. Assist and support other employees, teams, and sales personnel as necessary.

25. Know and apply the Quality System and any appropriate Federal and International standards.

Job Requirements:

Education: Bachelor's Degree from an accredited institution or equivalent work experience required

Experience: • Degree in Computer Science preferred

* 6 to 8 years' experience in Information Technology with a strong focus on solutions delivery of enterprise communications/collaboration platforms and network infrastructure
* Certifications in project management, collaboration platforms, network engineering, and user experience design are preferred

Functional/Technical Knowledge, Skills and Abilities Required: • Proven experience managing the implementation of enterprise technology solutions

* Proven technical skills and project implementation expertise designing, configuring, and deploying PaaS and SaaS based solutions
* Excellent documentation skills
* Excellent communication skills with the ability to explain technical topics in easily digestible manner
* Strong analytical skills to understand the essence of the business users' needs as well as dissect, assess, simplify, and document business processes and determine appropriate actions and solutions
* Experience successfully delivering Microsoft 365 productivity solutions
* Possess an ability to work comfortably and efficiently in a collaborative setting
* Exemplify creative problem solving
* General knowledge of User Experience based design methodologies and user centered design concept
* Proven experience with various WAN topologies including client and clientless VPN, site to site VPN, and SDWAN
* Ability to translate the organizational goals and objectives into strategic and tactical technology initiatives
* Knowledge of monitoring and configuration management platforms including SolarWinds
* Experience with network capacity planning, network security principles, and general network management best practices
* Working knowledge of infrastructure operating systems and platforms, including Silver Peak, Cisco IOS, Microsoft Server, and Linux Administration
* Strong knowledge of Cisco unified communications platforms both on premise and cloud based
* Extensive experience with WebEx and Microsoft Teams
* Experience with cloud networking and principles is desired
* Understanding of wireless vulnerabilities, WLAN-specific security threats, and software weaknesses, as well as mitigation strategies
* Working technical knowledge of current network hardware, protocols, and Internet standards
* Competence in IP telephony
* Knowledge of applicable data privacy practices and laws
* Strong interpersonal, written, and oral communication skills
* Able to conduct research into technical performance issues and products as required
* Highly self-motivated and directed, with keen attention to detail
* Proven analytical and problem-solving abilities
* Able to effectively prioritize tasks in a high-pressure environment
* Strong customer service orientation
* Experience working comfortably and efficiently in a team-oriented, collaborative environment

Core Competencies:

Work Standards Setting high standards of performance for self and others; assuming responsibility and accountability for successfully completing assignments or tasks; self-imposing standards of excellence rather than having standards imposed.

Contributing to Team Success Actively participating as a member of a team to move the team toward the completion of goals.

Building Strategic Work Relationships Developing and using collaborative relationships to facilitate the accomplishment of work goals.

Initiating Action Taking prompt action to accomplish objectives; taking action to achieve goals beyond what is required; being proactive.

Decision Making Identifying and understanding issues, problems, and opportunities; comparing data from different sources to draw conclusions; using effective approaches for choosing a course of action or developing appropriate solutions; taking action that is consistent with available facts, constraints, and probable consequences.

Planning and Organizing Establishing courses of action for self and others to ensure that work is completed efficiently.

QA Change Management Specialist II

Exactech, Inc.
Gainesville, FL
Purpose:

The "QA Change Management Specialist II" is a mid-level position within the Change Management group, whose primary responsibilities are associated to the processing of changes within Exactech Quality Management System.

Duties and Responsibilities (Key Deliverables):

* Maintain Exactech's change management system, including: change processing, control of documents and records.
* Organize and maintain required documents/records (paper or electronic) pertaining to change management, document management and records management, as part of Exactech's Quality Management System.
* Provide knowledge and assistance, as well as training, to Exactech's employees on the Change Management process.
* Act as a lead non-technical support role for change management applications.
* Work with Exactech Users and stake holding departments to understand and identify system opportunities for improvement.
* Assists in the development and maintenance of training materials and guidance documents for the Exactech Change Management systems.
* Know and apply the Quality System and any appropriate Federal and International standards.
* Assist and support other employees, teams, and sales personnel as necessary.

Senior Business Analyst

Exactech, Inc.
Gainesville, FL

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Exactech, Inc.
Gainesville, FL

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Exactech, Inc.
Sarasota, FL

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Exactech, Inc.
Gainesville, FL

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