Exactech
Exactech

4 Exactech Statistician Jobs Hiring Near You

Apply sound engineering problem-solving techniques to package/case development and maintenance tasks including design, statistical analysis, material selection, inspection requirements and ...

Degree in Allied Health, Statistics, Epidemiology, Life Sciences or Biomedical Engineering, highly preferred. * Minimum of 1 year of experience performing a complaint handling or post market ...

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.
Infographic showing various Statistician job openings at Exactech in the United States as of August 2026, with employment types broken down into 100% Full Time. Highlights an 87% Physical, and 13% Remote job distribution.

Senior Quality Engineer, Validation

Exactech

Gainesville, FL

$80K - $108K/yr

Full-time

Posted 24 days ago


Exactech rating

8.0

Company rating: 8.0 out of 10

Based on 6 frontline employees who took The Breakroom Quiz


Job description


This position offers flexibility to align with the candidate's experience level and can be structure as a Senior Validation Engineer role for those with advanced expertise.  

The Validation Engineer provides cross-functional support in V&V development, planning and execution while maintaining corporate engineering and quality systems best practices, policies and procedures. The Validation Engineer is results oriented and has the knowledge and confidence in the areas of Quality Assurance and validation/verification (V&V). 
  • 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. 
  • Participates in the development and execution of robust inspection and test methods for V&V feasibility and qualification projects and stand alone studies. 
  • Leads or participates in the validation of corporate software packages ensuring adherence to industry requirements. 
  • Use statistical techniques, as necessary, to properly design and execute V&V activities. 
  • 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, as necessary, supporting timely execution and closure of all corporate V&V activities.  
  • Maintain corporate validation process auditing program ensuring timely completion of auditing activities. 
  • Maintain V&V planning (Validation Project Dashboard) documenting progress towards completion of corporate V&V initiatives in preparation for monthly update meetings. 
  • Lead the identification, maintenance, development and enhancement of corporate systems, processes and standards. 
  • Identify, analyze and correct internal and external manufacturing deviations and/or anomalies related to V&V activities ensuring optimization of production processes. 
  • Successfully contribute to cross-functional project teams in all areas of device cleanliness and manufacturing V&V work such as material testing, specification development, process capability studies, research, and investigation and process/test documentation. 
  • Identify and communicate significant quality and compliance concerns to the Mgr. Validations, QA and associated project team leaders early in the V&V development phase. 
  • Informs Regulatory Affairs of validation projects that may require further reporting/scrutiny (e.g. PMA devices). 
  • Participate in the review and qualification of external supply chain V&V activities. 
  • Take primary responsibility for company-wide validation related Corrective and Preventive Actions that may result from internal/external non-conformances, recalls and/or field actions. 
  • Define and lead third party, customer and regulatory audits as they pertain to validations. 
Education:
  • Bachelor's Degree from an accredited institution required; Master's Degree preferred  
 Experience:
  • Advanced level of technical software proficiency 
  • Excellent Quality System knowledge required 
  • Strong time management and project management skills are necessary. 
  • Experience writing IQ/OQ/PQ V&V protocols. 
  • Working knowledge of principles, concepts and practices of process V&V activities, Risk Management, FDA and ISO Regulations.  
  • General understanding of sterilization and related analytical testing is a plus. 
    Must be able to work independently and in a team environment.  
Functional/Technical Knowledge, Skills and Abilities Required:
  • Statistical expertise in areas such as process capability, process assurance and sampling 
  • Expertise in Microsoft Office products 
  • Ability to work effectively in a team environment 
  • ASQ Certifications preferred 
  • Advanced level of technical software proficiency 
  • Working knowledge of statistical analysis and sampling plans. 
  • Excellent communication (written and verbal) skills. 
  • Excellent organization skills. 


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