The Quality Systems Engineer, Senior is a top-level leader, developing and supporting the company's Quality Management Systems, ensuring adherence to domestic and international regulations and ...
30 Exactech Jobs Hiring Near You
The Quality Systems Engineer, Senior is a top-level leader, developing and supporting the company's Quality Management Systems, ensuring adherence to domestic and international regulations and ...
IT Support Engineer
Gainesville, FL · On-site
Serves as the highest level of technical escalation within the service desk, responsible for resolving complex issues, driving root cause analysis, and leading continuous improvement across IT suppor ...
New
IT Support Engineer
Gainesville, FL · On-site
Serves as the highest level of technical escalation within the service desk, responsible for resolving complex issues, driving root cause analysis, and leading continuous improvement across IT suppor ...
New
CNC Machine Operator (All Levels)
Gainesville, FL · On-site
$18.50 - $25.25/hr
Manufacture implants and instruments at an introductory level. * Operate CNC machines with minimal assistance. * Work from written instructions; (Work Instructions) * Be able to adjust offsets to ...
CNC Machine Operator (All Levels)
Gainesville, FL · On-site
$18.50 - $25.25/hr
Manufacture implants and instruments at an introductory level. * Operate CNC machines with minimal assistance. * Work from written instructions; (Work Instructions) * Be able to adjust offsets to ...
The Sr. Project Manager - Operations is responsible for leading and delivering cost reduction ("cost-out") initiatives across operations, engineering, and the product lifecycle. The role ensures that ...
The Sr. Project Manager - Operations is responsible for leading and delivering cost reduction ("cost-out") initiatives across operations, engineering, and the product lifecycle. The role ensures that ...
Intern - Eng Test Lab
Gainesville, FL · On-site
$15.25 - $19.75/hr
Provide design, engineering, and analysis support to other engineers and designers in the development and maintenance of orthopedic implants and instruments. * Primary: * Apply engineering acumen to ...
Intern - Eng Test Lab
Gainesville, FL · On-site
$15.25 - $19.75/hr
Provide design, engineering, and analysis support to other engineers and designers in the development and maintenance of orthopedic implants and instruments. * Primary: * Apply engineering acumen to ...
Design Engineer, Packaging
Gainesville, FL · On-site
$123K/yr
Design and development of medical device packaging or sterilization cases. Includes qualification/testing of packaging configurations and process validation. * Under supervision, design and develop ...
Design Engineer, Packaging
Gainesville, FL · On-site
$123K/yr
Design and development of medical device packaging or sterilization cases. Includes qualification/testing of packaging configurations and process validation. * Under supervision, design and develop ...
The Assistant General Counsel, Commercial supports the organization by providing legal counsel on commercial transactions, employment-related matters, and other legal risk areas to ensure alignment ...
The Assistant General Counsel, Commercial supports the organization by providing legal counsel on commercial transactions, employment-related matters, and other legal risk areas to ensure alignment ...
Designer
Gainesville, FL · On-site
Design orthopedic implants, instrumentation, and related components under the guidance of senior engineering and design personnel. Produce CAD models, drawings, prototypes, and design documentation ...
Designer
Gainesville, FL · On-site
Design orthopedic implants, instrumentation, and related components under the guidance of senior engineering and design personnel. Produce CAD models, drawings, prototypes, and design documentation ...
The Manager, Quality Engineering, provides leadership to the Quality Engineering team by inspiring individuals and teams while creating an environment of organizational excellence to deliver results.
The Manager, Quality Engineering, provides leadership to the Quality Engineering team by inspiring individuals and teams while creating an environment of organizational excellence to deliver results.
The New Product Development (NPD) Engineer is responsible for representing Manufacturing Engineering throughout the product development lifecycle. This role serves as the voice of manufacturing on ...
The New Product Development (NPD) Engineer is responsible for representing Manufacturing Engineering throughout the product development lifecycle. This role serves as the voice of manufacturing on ...
Exactech Jobs Information
Do workers at Exactech get paid breaks?
Sometimes. Only some people get paid breaks.
40% of people say they don’t get paid breaks.
Based on data from 5 people who took the Breakroom Quiz between February 2025 and March 2026.
40% of people say they don’t get paid breaks.
Based on data from 5 people who took the Breakroom Quiz between February 2025 and March 2026.
Does Exactech pay people when they’re sick?
Sometimes. Only some people get paid when they’re sick.
40% of people say they wouldn’t get paid if they were sick but scheduled to work.
Based on data from 5 people who took the Breakroom Quiz between February 2025 and August 2025.
40% of people say they wouldn’t get paid if they were sick but scheduled to work.
Based on data from 5 people who took the Breakroom Quiz between February 2025 and August 2025.
Do Exactech workers get to choose the shifts they work?
Some people don’t get to choose which shifts they work.
60% report that they don’t have enough control over which shifts they work.
Based on data from 5 people who took the Breakroom Quiz between February 2025 and August 2025.
60% report that they don’t have enough control over which shifts they work.
Based on data from 5 people who took the Breakroom Quiz between February 2025 and August 2025.
How easy is it to get time off at Exactech?
Most people find it easy to get time off.
67% of people report it’s easy to get time off.
Based on data from 6 people who took the Breakroom Quiz between February 2025 and March 2026.
67% of people report it’s easy to get time off.
Based on data from 6 people who took the Breakroom Quiz between February 2025 and March 2026.
Do Exactech managers change schedules at the last minute?
Most managers don’t change people’s schedules at the last minute.
100% of people say their manager doesn’t change their shift schedule at the last minute.
Based on data from 5 people who took the Breakroom Quiz between February 2025 and August 2025.
100% of people say their manager doesn’t change their shift schedule at the last minute.
Based on data from 5 people who took the Breakroom Quiz between February 2025 and August 2025.
Do jobs at Exactech spill into time workers aren’t paid for?
Rarely. The job doesn't usually spill into unpaid time.
20% of people report that their job takes up time that they don’t get paid for.
Based on data from 5 people who took the Breakroom Quiz between February 2025 and August 2025.
20% of people report that their job takes up time that they don’t get paid for.
Based on data from 5 people who took the Breakroom Quiz between February 2025 and August 2025.
How easy is it to take sick days at Exactech?
Some people find it hard to take sick days.
67% of people report that it’s hard to take time off if they are sick.
Based on data from 6 people who took the Breakroom Quiz between February 2025 and March 2026.
67% of people report that it’s hard to take time off if they are sick.
Based on data from 6 people who took the Breakroom Quiz between February 2025 and March 2026.
Do people at Exactech feel treated with respect by their managers?
Some people don’t feel treated with respect by their managers.
60% of people say they’re not treated with respect by their managers.
Based on data from 5 people who took the Breakroom Quiz between February 2025 and March 2026.
60% of people say they’re not treated with respect by their managers.
Based on data from 5 people who took the Breakroom Quiz between February 2025 and March 2026.
Is it stressful to work at Exactech?
Some people feel stressed here.
67% of people say they often feel stressed at work.
Based on data from 6 people who took the Breakroom Quiz between February 2025 and March 2026.
67% of people say they often feel stressed at work.
Based on data from 6 people who took the Breakroom Quiz between February 2025 and March 2026.
Do people at Exactech enjoy their jobs?
Only some people enjoy their job.
50% of people report they don’t enjoy their job.
Based on data from 6 people who took the Breakroom Quiz between February 2025 and March 2026.
50% of people report they don’t enjoy their job.
Based on data from 6 people who took the Breakroom Quiz between February 2025 and March 2026.
Do people at Exactech recommend working with their team?
Only some people recommend working with their team.
67% of people report that they wouldn’t recommend working with their immediate team to a friend.
Based on data from 6 people who took the Breakroom Quiz between February 2025 and March 2026.
67% of people report that they wouldn’t recommend working with their immediate team to a friend.
Based on data from 6 people who took the Breakroom Quiz between February 2025 and March 2026.
Do people get enough training when they start at Exactech?
Some people didn’t get enough training when they started.
67% of people report they didn’t get enough training when they started working here.
Based on data from 6 people who took the Breakroom Quiz between February 2025 and March 2026.
67% of people report they didn’t get enough training when they started working here.
Based on data from 6 people who took the Breakroom Quiz between February 2025 and March 2026.
Do people get support to advance at Exactech?
Only some people are given support to advance their career here.
In the last year, 50% of people report not being given support to advance their career here.
Based on data from 6 people who took the Breakroom Quiz between February 2025 and March 2026.
In the last year, 50% of people report not being given support to advance their career here.
Based on data from 6 people who took the Breakroom Quiz between February 2025 and March 2026.
Do people think Exactech’s headquarters understands what’s happening where they work?
Most people think headquarters doesn’t understand what’s happening where they work.
100% of people think that this employer’s headquarters or owners don’t have a good understanding of what’s really happening where they work.
Based on data from 5 people who took the Breakroom Quiz between February 2025 and August 2025.
100% of people think that this employer’s headquarters or owners don’t have a good understanding of what’s really happening where they work.
Based on data from 5 people who took the Breakroom Quiz between February 2025 and August 2025.
Do workers feel well informed about how Exactech is doing?
Most people don’t feel well informed about how the company is doing.
80% of people feel that they aren’t kept well informed about how the company is doing as a whole.
Based on data from 5 people who took the Breakroom Quiz between February 2025 and March 2026.
80% of people feel that they aren’t kept well informed about how the company is doing as a whole.
Based on data from 5 people who took the Breakroom Quiz between February 2025 and March 2026.
What are the most popular titles at Exactech?
What are the most popular cities for Exactech jobs?
What are the most popular job types at Exactech?
Exactech rating
8.0
Based on 6 frontline employees who took The Breakroom Quiz
Job description
The Quality Systems Engineer, Senior is a top-level leader, developing and supporting the company's Quality Management Systems, ensuring adherence to domestic and international regulations and company policies.
- Quality Systems and Regulatory Compliance:
- Know and apply the Quality System and any appropriate Federal and International standards (FDA, ISO 13485, MDSAP, EU MDR, etc.)
- Provide leadership and strategy for the team in the overall administration and maintenance of the QMS processes, ensuring alignment with organizational goals.
- Ensure that Quality Management Systems documentation meets the required guidelines for maintaining FDA compliance and ISO/EC/MDR certification.
- Support the strategic initiatives of the company to achieve and maintain regulatory compliance.
- Corrective and Preventive Action:
- Oversees CAPA system, including maintenance, development and system validation.
- Develops and facilitates continuous training and development for the CAPA process, including root cause analysis and verification of effectiveness.
- Responsible for the reporting of CAPA system KPIs during Quality Systems Governance and Management Review.
- Operates as lead Subject Matter Expert during internal/external audits and inspections..
- Product/Process Nonconformance:
- Oversees NC system, including maintenance, development and system validation.
- Supports cross-functional teams with investigations, root cause analysis, escalation decisions, and dispositions.
- Operates as lead Subject Matter Expert during internal/external audits and inspections.
- Product Corrections and Removals:
- Oversees the process for product event escalations, health hazard evaluation, and execution of product corrections and removals.
- Provides guidance and drives cross-functional collaboration to make timely decisions, based upon product risk.
- Supports cross-functional teams with investigations, root cause analysis, escalation decisions, and final decisions.
- Operates as lead Subject Matter Expert during internal/external audits and inspections.
- Training and Cross-Functional Responsibilities:
- Oversees the Learning Management Solution (LMS), including maintenance, development and system validation.
- Develop training and competency solutions to meet the needs of the company and its Quality Management System.
- Monitors Quality Systems training curricula for completeness, appropriateness and execution.
- Responsible for the reporting of LMS system KPIs during Quality Systems Governance and Management Review.
- Operates as lead Subject Matter Expert during internal/external audits and inspections.
- Data Analytics & Reporting Responsibilities:
- Assist with the development of training materials and documentation to ensure effective dissemination of knowledge to team members and stakeholders.
- Responsible for compiling process data for presentation during Quality Systems Governance and Management Reviews.
- Facilitates Quality Systems Governance and Management Review meetings in accordance with company procedures.
Education:
- Bachelor's Degree in Engineering or related science from an accredited institution required; Master's Degree preferred.
Experience:
- Minimum of 6 years full-time medical device engineering/quality/regulatory technical experience. This experience shall be in addition to any college internships. Relevant experience in other areas may be considered.
- Experience in Change Management documentation systems preferred.
- Experience in electronic Quality Management Systems solutions (e.g. SmartSolve IQVIA, Cornerstone, Teamcenter).
- Experience in data management and reporting utilizing PowerBI.
- Professional Certification through the American Society for Quality (ASQ) or equivalent in Auditing for Medical Devices.
- Experience in software validation, operating within a Quality Management System
Functional/Technical Knowledge, Skills and Abilities Required:
- Demonstrated ability to lead cross-functional teams and project
- Demonstrated ability to communicate effectively quality related discussions
- Experience with the development, implementation, and maintenance of electronic solutions for Quality Management Systems elements such as: CAPA, Audits, Data Analysis, etc.
- Demonstrable knowledge of all domestic and international Quality System regulations.