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Contract Medical Device Auditor Jobs in Boca Raton, FL

Actalent

Device Technician

Boca Raton, FL

$25 - $28/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Experience with medical devices, medical device assembly, and repair. * Ability to support ... Job Type & Location This is a Contract position based out of Boca Raton, FL. Pay and Benefits The ...

New

atrion

Sr. Manager - Quality Assurance

Davie, FL · On-site

EU Medical Device Directive (93/42/EEC); Canadian Medical Devices Regulation (SOR98-282); Japanese ... Certified Lead Auditor or ASQ certification as a Certified Quality Auditor (CQA), Certified Quality ...

Open Scientific

Regulatory Manager

Sunrise, FL

Company Description Open Scientific provides contract staffing and direct hire recruitment services ... Develop medical device regulatory submissions in accordance with FDA requirements (e.g., pre ...

atrion

Quality Engineering Manager

Davie, FL · On-site

... auditing, and risk management activities with respect to global regulatory requirements and MDSAP ... Excellent working knowledge of medical device regulations and industry standards pertaining to ...

atrion

Quality Engineer

Davie, FL · On-site

$66K - $85K/yr

A minimum of 5 years' experience in the medical device manufacturing industry is preferred ... Certified Lead Auditor and Six Sigma Green or Black Belt preferred. * Previous experience ...

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Contract Medical Device Auditor information

See Boca Raton, FL salary details

$13

$20

$27

How much do contract medical device auditor jobs pay per hour?

As of Aug 20, 2026, the average hourly pay for contract medical device auditor in Boca Raton, FL is $20.52, according to ZipRecruiter salary data. Most workers in this role earn between $16.44 and $26.01 per hour, depending on experience, location, and employer.

What is a contract medical device auditor?

Contract Medical Device Auditors are professionals who are hired on a contractual basis to assess and evaluate medical device companies for compliance with regulatory standards such as ISO 13485, FDA regulations, and other applicable quality management systems. They conduct audits, prepare reports, and help organizations identify areas for improvement to ensure the safety and effectiveness of medical devices. These auditors often work independently or through consulting firms, traveling to different manufacturers to perform assessments.

How does a contract medical device auditor typically collaborate with client teams during an audit?

As a Contract Medical Device Auditor, you work closely with client teams throughout the audit process. This includes conducting opening and closing meetings, interviewing staff, and reviewing documentation to ensure compliance with regulatory standards such as ISO 13485 or FDA requirements. Effective communication and professionalism are essential, as the auditor often needs to explain findings, answer questions, and provide guidance on corrective actions. Building a collaborative relationship helps ensure audits are thorough, constructive, and support continuous improvement for the client.

What are the key skills and qualifications needed to thrive as a contract medical device auditor, and why are they important?

To thrive as a Contract Medical Device Auditor, you need a strong understanding of quality management systems, regulatory standards (such as ISO 13485), and experience in medical device manufacturing or compliance, often supported by relevant certifications. Familiarity with audit management software, document control systems, and regulatory databases is typically required. Outstanding attention to detail, analytical thinking, and effective communication are critical soft skills for evaluating compliance and reporting findings. These skills ensure thorough, accurate audits that help organizations meet regulatory requirements and maintain product safety and quality.

What is the difference between Contract Medical Device Auditor vs Contract Quality Assurance Specialist?

AspectContract Medical Device AuditorContract Quality Assurance Specialist
CertificationsISO 13485 Lead Auditor, FDA regulationsISO 13485, FDA compliance, GMP training
Work EnvironmentAuditing facilities, reviewing documentationDeveloping, implementing quality processes
Employer & IndustryMedical device companies, consulting firmsMedical device manufacturers, biotech firms
Search & Comparison IntentUnderstanding auditing roles, compliance checksQuality management, process improvement

While both roles focus on ensuring medical device quality, Contract Medical Device Auditors primarily conduct audits to verify compliance with standards like ISO 13485 and FDA regulations. Contract Quality Assurance Specialists develop and maintain quality systems, ensuring ongoing compliance and process improvements. The auditor role is more inspection-focused, whereas the QA specialist role involves proactive quality management.

What are popular job titles related to Contract Medical Device Auditor jobs in Boca Raton, FL?

For Contract Medical Device Auditor jobs in Boca Raton, FL, the most frequently searched job titles are:

What job categories do people searching Contract Medical Device Auditor jobs in Boca Raton, FL look for?

The top searched job categories for Contract Medical Device Auditor jobs in Boca Raton, FL are:

Contract Medical Device Auditor jobs near you
Infographic showing various Contract Medical Device Auditor job openings in Boca Raton, FL as of August 2026, with employment types broken down into 1% As Needed, 76% Full Time, 17% Part Time, and 6% Contract. Highlights an 89% Physical, 1% Hybrid, and 10% Remote job distribution, with an average salary of $42,673 per year, or $20.5 per hour.

External Auditor Physician

Omega Healthcare Management Services Pvt. Ltd.

Boca Raton, FL • On-site

$120 - $180/hr

Other

Medical, Dental, Vision, Retirement, PTO

Posted 2 days ago

New

Job description

Under general supervision of client, Omega’s External Auditor Physician will perform reviews of inpatient and outpatient or Professional Services medical records for coding accuracy and medical record documentation as it impacts the accuracy of ICD-10-CM, ICD-10-PCS codes driving MS-DRG assignment and ICD-10-CM and CPT-4/HCPCS codes driving the APC assignment.The External Auditor Physician must be able to identify Physician query opportunities, write compliant queries, assess the accuracy of POA, discharge disposition and modifier assignments. External Auditor Physician performs data collection for quality and statistical purposes and reports the findings to Omega’s clients.

Essential Job Functions

Reviewinpatient,outpatient,orphysicianservicesmedicalrecordsforaccuracyofcodinganddataquality. Elements to be included in reviews can include:

AlldiagnosisandprocedureassignedICD-10-CMandICD-10PCS codes

AlldiagnosisandprocedureassignedICD-10-CMandICD-10PCS codes

AllCPTassigned codes

APCassignment Professional Services

AllCPT codes

AllE&MLeveling codes

MaintainauditingproductivitybasedonClientandOmegaagreedupon requirements

Utilize all available official references to perform reviews: to include but not limited to International ClassificationofDiseases,9 th Edition,ClinicalModification(ICD-9-CM),theCurrentProceduralTerminology (CPT-4) Official Coding Guidelines, Coding Clinic, CPT Assistant, CMS guidelines, etc.

  • Demonstratestrongorganizationalskillsandbedetail oriented.
  • Demonstrateabilitytoself-motivate,setgoals,andmeet deadlines.

Abilitytodevelopandmaintainrelationshipswithkeybusinesspartnersbybuildingpersonalcredibilityand trust.

Maintainscourteousandprofessionalworkingrelationshipswithemployeesatalllevelsofthe organization.

  • Demonstrateexcellentanalytical,criticalthinkingandproblem-solving skills.
  • Abilitytoidentifydeficienciesandtakecorrective action.

Thephysicaldemandsdescribedherearerepresentativeofthosethatmustbemetbyanemployeeto successfully perform the essential functions of this job.

While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger,handle,orfeelobjects,tools,orcontrols;reachwithhandsandarms;climbstairs;balance;stoop,kneel, crouchorcrawl;andtalkorhear.Theemployeemustoccasionallyliftormoveupto25pounds.Specificvision abilities required by the job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus.

Position Type/Expected Hours of Work

This is a full-time position.Days and hours of work are generally Monday through Friday, 8:00 a.m. to 5 p.m. This position occasionally requires long hours and weekend work.

Musthaveatleasttwoyearsof HIMexperience,preferablyasan Auditor.

Atleastoneyearofauditing experience.

Minimumofsuccessfulcompletionofan AHIMA approvedCodingCertificate Program.

Preferred Education and Experience

None.

Additional Eligibility Qualifications

CCS, CPC, CPC-P, CPC-H, RHIA or RHIT

Security Access Requirements

In addition to the specific security access required by the employee’s client engagement, the employee will have access to the Omega systems set forth in the “Standard Field Employee” profile.

Microsoft Office

ADP

Oracle

E1- All Field Employees

Standard Employee

Standard

Coder and Client Access based on client needs. Determined by manager and granted by Audit Implementation Manager

Omega Healthcare is an Equal Employment Opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, gender, age, sexual orientation, gender identity or expression, marital status, mental or physical disability, protected veteran status, and genetic information, or any other basis protected by applicable law. Omega Healthcarealso prohibits harassment of applicants or employees based on any of these protected categories.

Omega Healthcare makes reasonable accommodations when needed for applicants and candidates with disabilities or religious observances. If reasonable accommodation is needed to participate in the job application, interview, or any other part of the hiring process, please contact Human Resources at employeerelationsus@omegahms.com .

Founded in 2003, Omega Healthcare Management Services® (Omega Healthcare) empowers healthcare to thrive via intelligent solutions that optimize revenue cycle operations, administrative workflows, care coordination, and clinical research on a global scale. The company works with providers, payers, life science companies, medical device manufacturers, health technology firms, researchers, and industry partners to amplify teams with robust technology, specialty expertise, and operational support. Omega Healthcare serves more than 350 healthcare organizations with 35,000 skilled workers in the United States, India, Colombia, and the Philippines. For more information, visitwww.omegahms.com

We offer a comprehensive benefits package that may include health, dental, and vision coverage, voluntary insurance options, a 401(k) plan with employer match, professional development opportunities, paid time off, and holiday pay. Eligible employees may also have the opportunity to participate in bonus programs, commissions, or other variable incentive plans. Benefits and incentive eligibility may vary based on position, location, and tenure.

AAP/EEO Statement

Omega Healthcare is an Equal Employment Opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, gender, age, sexual orientation, gender identity or expression, marital status, mental or physical disability, protected veteran status, and genetic information, or any other basis protected by applicable law. Omega Healthcarealso prohibits harassment of applicants or employees based on any of these protected categories.

Omega Healthcare makes reasonable accommodations when needed for applicants and candidates with disabilities or religious observances. If reasonable accommodation is needed to participate in the job application, interview, or any other part of the hiring process, please contact Human Resources at employeerelationsus@omegahms.com .

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