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Biomedical Auditor Jobs (NOW HIRING)

Nova Biomedical

Senior Quality Director

Waltham, MA · Hybrid

$220K - $300K/yr

... quality auditing processes; improvements. Primary responsibilities includes managing corporate level compliance activities along with day-to-day quality activities at the global Nova Biomedical ...

Nova Biomedical

Senior Quality Director

Waltham, MA · Hybrid

$220K - $300K/yr

... quality auditing processes; improvements. Primary responsibilities includes managing corporate level compliance activities along with day-to-day quality activities at the global Nova Biomedical ...

Nova Biomedical

Senior Quality Director

Waltham, MA · On-site

$220K - $300K/yr

... quality auditing processes; improvements. Primary responsibilities includes managing corporate level compliance activities along with day-to-day quality activities at the global Nova Biomedical ...

Integer

Quality Engineer III

Plymouth, MN

$93K - $136K/yr

Certified Quality Engineering (CQE), Certified Software Quality Engineer (CSQE), Certified Reliability Engineer (CRE), Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA), or Six ...

Nova Biomedical

Quality Engineer II

Westbrook, ME

$73K - $94K/yr

Nova Biomedical: One Global Brand. One Vision. Together under one name. Advanced Instruments and ... internal auditing, investigations, process controls, change management, quality records, and ...

Nova Biomedical

Quality Engineer II

Westbrook, ME

$73K - $94K/yr

Nova Biomedical: One Global Brand. One Vision. Together under one name. Advanced Instruments and ... internal auditing, investigations, process controls, change management, quality records, and ...

Nova Biomedical

Quality Engineer II

Westbrook, ME · On-site

$73K - $94K/yr

Nova Biomedical: One Global Brand. One Vision. Together under one name. Advanced Instruments and ... internal auditing, investigations, process controls, change management, quality records, and ...

Gauthier Biomedical Inc.

Be Seen First

Bookkeeper / Accounts Payable

Grafton, WI · On-site

Assembles information for external auditors as necessary. * Maintains an effective and orderly ... Gauthier Biomedical is a proud manufacturer of high-quality instruments for the medical device ...

IQVIA

Quality Specialist/ Biomedical Technician

Chicago, IL

$18.50 - $25/hr

Summary Experienced Biomedical Technician or Quality/Regulatory Inspector needed who's willing to ... Experience with system auditing or software validation preferred. * Experience with large data sets ...

IQVIA

Quality Specialist/ Biomedical Technician

Dallas, TX

$17.75 - $24/hr

Summary Experienced Biomedical Technician or Quality/Regulatory Inspector needed who's willing to ... Experience with system auditing or software validation preferred. * Experience with large data sets ...

IQVIA

Quality Specialist/ Biomedical Technician

Dallas, TX

$17.75 - $24/hr

Summary Experienced Biomedical Technician or Quality/Regulatory Inspector needed who's willing to ... Experience with system auditing or software validation preferred. * Experience with large data sets ...

IQVIA

Quality Specialist/ Biomedical Technician

Chicago, IL

$18.50 - $25/hr

Summary Experienced Biomedical Technician or Quality/Regulatory Inspector needed who's willing to ... Experience with system auditing or software validation preferred. * Experience with large data sets ...

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Biomedical Auditor information

See salary details

$33K

$76.3K

$121.5K

How much do biomedical auditor jobs pay per year?

As of Jun 10, 2026, the average yearly pay for biomedical auditor in the United States is $76,256.00, according to ZipRecruiter salary data. Most workers in this role earn between $53,500.00 and $98,500.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Biomedical Auditor, and why are they important?

To thrive as a Biomedical Auditor, a solid background in biomedical sciences, auditing principles, and regulatory compliance—often supported by a bachelor's degree and relevant certifications—is essential. Familiarity with quality management systems (such as ISO 13485), audit management software, and regulatory databases is typically required. Exceptional analytical thinking, attention to detail, and strong communication skills help auditors effectively assess processes and convey findings. These skills ensure biomedical organizations maintain compliance, uphold safety standards, and continually improve product quality.

What are some common challenges faced by Biomedical Auditors during on-site assessments?

Biomedical Auditors often encounter challenges like navigating complex regulatory requirements, ensuring compliance across diverse medical equipment, and maintaining up-to-date knowledge of industry standards. On-site assessments may involve working with multidisciplinary teams, managing tight schedules, and addressing unforeseen compliance gaps. Successful auditors develop strong communication and organizational skills to effectively collaborate with healthcare staff and provide actionable recommendations.

What is the difference between Biomedical Auditor vs Clinical Compliance Specialist?

AspectBiomedical AuditorClinical Compliance Specialist
Required CertificationsCertified Biomedical Auditor (CBIA), RACCertified Clinical Research Professional (CCRP), RAC
Work EnvironmentHospitals, medical device companies, regulatory agenciesClinical research sites, pharmaceutical companies, healthcare organizations
Employer & Industry UsageRegulatory bodies, medical device manufacturers, healthcare facilitiesPharmaceutical firms, clinical research organizations, hospitals

Biomedical Auditors focus on evaluating compliance of biomedical equipment, devices, and related processes with regulations, often working in healthcare facilities or medical device companies. Clinical Compliance Specialists primarily ensure clinical research and trial activities adhere to regulatory standards. While both roles require similar certifications and work in healthcare-related environments, Biomedical Auditors concentrate on equipment and device compliance, whereas Clinical Compliance Specialists focus on clinical trial processes and research compliance.

What are biomedical auditors?

Biomedical auditors are professionals who assess and ensure compliance with regulatory standards and quality management systems within biomedical organizations, such as medical device manufacturers, laboratories, and healthcare facilities. They review processes, documentation, and products to verify adherence to laws like FDA regulations, ISO standards, and Good Laboratory Practices (GLP). Their work helps maintain patient safety, product effectiveness, and organizational compliance. Biomedical auditors often conduct internal and external audits, identify areas for improvement, and recommend corrective actions to ensure continuous quality improvements.
What states have the most Biomedical Auditor jobs? States with the most job openings for Biomedical Auditor jobs include:
Biomedical Auditor jobs near you
Infographic showing various Biomedical Auditor job openings in the United States as of June 2026, with employment types broken down into 1% As Needed, 88% Full Time, 10% Part Time, and 1% Contract. Highlights an 87% Physical, 2% Hybrid, and 11% Remote job distribution, with an average salary of $76,256 per year, or $36.7 per hour.

Supplier Quality Engineer

Accord Technologies Inc.

Latham, NY • On-site

Contractor

Posted 17 days ago

Job description

Title: Supplier Quality Engineer
Location : Latham, NY
Domain: Medical Device industry.

 
Job Description
    • Implement Quality Engineering, Purchasing Controls, and Supplier Quality processes related to the development, procurement, and continuous improvement of manufacturing materials, components, software, sub-assemblies, contract manufactured finished devices, products, or services.
    • Evaluate suppliers' critical quality processes and ensure compliance with regulatory requirements and procedures.
    • Drive supplier improvement via SQIPs (Supplier Quality Improvement Plans) and lead the Supplier Change Notice process with support from Engineering, Quality Engineering, Assurance,
    • Qualify suppliers, assess their metrics, and audit their critical quality processes.
    •  Ensure validations are completed where specified and control plans exist to ensure sustained quality and compliance of supplied raw materials and components.
    •  Independently Produces and completes Supplier Quality Engineering related activities and documentation.
    • Completes Qualification of materials and components (including spare parts), development/ improvement of supplier processes for CtQ's, supplier process control plans; ensuring that the supplied part meets specifications, and the control limits/tolerances for CtQ parameters are met.
    • Qualifies and sustains sub- processes of suppliers, including performing process validations for critical supplier processes impacting part quality.
    • Ensures that the components/products at the supplier (including spare parts and services) are released according agreed specification and quality requirements (APQP / PPAP), and SQ audit results.
    •  Executes SCAR management, effective and timely closure Regulatory, ME, R&D, Clinical, etc.
    • Experience in leading process improvement methodologies and organizational change management.
    • Proven record of accomplishment in developing suppliers and implementing lean methodologies at supplier end.
    • Develop and support regulatory compliance gaps at suppliers, including supplier quality system and process development activities.
    • Manage additions/deletions/changes to the status of suppliers on the Approved Supplier List, including supplier master file records
    • Ensure raw materials/components/products at supplier(s) are released from supplier(s) according to the agreed requirements.
    • Perform 3rd party product compatibility risk assessments in partnership with R&D and Market Procurement (Markets SQE).
    • Drive quality and compliance development and/or improvement at suppliers when needed.
Required Skills and Qualifications:
 
    • Bachelor’s degree in engineering or science discipline, or equivalent experience.
    • A minimum of 4 to 8 years of experience in establishing and maintaining regulated supplier management systems.
    • Engineer quality and ensure compliance for raw materials, components, finished products etc.
    • Certification with a recognized Accreditation body (i.e., RAB-QSA/IRCA) or successful completion of ASQ certification as a Certified Quality Engineer(CQE) and Certified Quality will be advantage.
    •  Any Auditor (CQA) or Certified Biomedical Auditor or successful completion of a recognized Lead Auditor course will be added advantage.
    • Excellent communication skills in English (written and verbal).
    • Demonstrated experience in collaborative working environments, conflict resolution, and stakeholder influencing.
    • Ability to drive progress, take initiative, and achieve results.
    • Experience with technical drawings, specifications of parts.
    • Experience in Manufacturing process of welding, soldering, crimping, injection molding, plating, casting, and thermal forming
    • Experience with APQP (IQ,OQ,PQ) preferred.
    • Technical writing of protocols and reports.
    •  Experience in ISO 9001, 13485 a plus.
    • Ability to travel to supplier sites within assigned region.
    • Looking for candidate who has extensive medical device domain industry experience.