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Biomedical Auditor Jobs (NOW HIRING)

BSI Group

Medical Device QMS Auditor

Concord, NC · Remote

$98K - $123K/yr

Relevant fields include Biomedical, Mechanical, Electrical, or Chemical Engineering; Materials ... Experience auditing or assessing quality management systems compliant with ISO 13485, CE Marking ...

Excelitas Technologies

Quality Engineer

Boulder, CO · On-site

$100K - $130K/yr

... biomedical, semiconductor, industrial, consumer products, scientific, security, defense and ... ISO 9001 internal auditor or lead auditor training. * Strong background in statistics, SPC, and ...

Excelitas Technologies

Quality Engineer

Boulder, CO

$100K - $130K/yr

... biomedical, semiconductor, industrial, consumer products, scientific, security, defense and ... ISO 9001 internal auditor or lead auditor training. * Strong background in statistics, SPC, and ...

Columbia University

Senior Clerk

Manhattan, NY · On-site

... auditing the data collection system for completion of tasks and entries (REDCap). * Contacting ... Bachelor's degree in relevant fields (psychology, neuroscience, biomedical engineering, electrical ...

BPI Medical

Instrument Repair Technician

Fife, WA · On-site

Certified Registered Central Service Technician (CRCST), Certified Biomedical Equipment Technician (BMET), or ISO 13485:2016 internal auditor credential. * Familiarity with AAMI ST91 and IEC 60601-2 ...

Actalent

Quality Manager

Saint Paul, MN · On-site

Bachelor's degree in Engineering (such as Biomedical, Mechanical, Electrical, or Industrial ... Experience with supplier qualification, auditing, and ongoing supplier management in a regulated ...

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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 Aug 14, 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 is a biomedical auditor?

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 August 2026, with employment types broken down into 2% Internship, 1% As Needed, 69% Full Time, 25% Part Time, and 3% Contract. Highlights an 88% Physical, 2% Hybrid, and 10% Remote job distribution, with an average salary of $76,256 per year, or $36.7 per hour.

Manager, Biomedical Engineering

St. Luke's University Health Network

Bethlehem, PA • On-site

Full-time

This job post has expired today. Applications are no longer accepted.

St. Luke's University Health Network rating

7.1

Company rating: 7.1 out of 10

Based on 270 frontline employees who took The Breakroom Quiz

381st of 887 rated healthcare providers

Job description

St. Luke's is proud of the skills, experience and compassion of its employees. The employees of St. Luke's are our most valuable asset! Individually and together, our employees are dedicated to satisfying the mission of our organization which is an unwavering commitment to excellence as we care for the sick and injured; educate physicians, nurses and other health care providers; and improve access to care in the communities we serve, regardless of a patient's ability to pay for health care.
The Manager, Biomedical Engineering Leads personnel and departmental functions related to the repair, maintenance, routine testing and support of clinical equipment. Leads the department in a dual function of providing access to medical equipment & providing cost avoidance / financial savings for the organization. Establishes and ensures compliance with all timelines through working with various disciplines both internal and external. Provide leadership for the medical equipment management program, departmental policies & procedures.
JOB DUTIES AND RESPONSIBILITIES:
  • Leads employees by hiring, establishing annual performance goals, allocating resources, assessing annual performance, coordinating training, coaching, and determining individual merit, incentive and/or promotional increases
  • Ensures department compliance with all aspects of the Environment of Care Medical Equipment Management Plan, Joint Commission and other regulatory requirements
  • Provides fiscal leadership. Approves Purchase Order requests and Invoices after work is performed. Fiscally manages assignments to ensure departmental budget compliance. Assist in managing repairs at the minimum possible cost to the institution while maintaining the highest level of patient care and quality. Manages vendors and contracts as required. Leads resources in excess of $2,000,000 annually
  • Assigns work and schedules employees to ensure that all assignments are completed in a timely manner
  • Assists with special project work. Leads various departmental efforts and outside contractors to develop timelines and ensures compliance with project timelines
  • Attends meetings and participates on various committees
  • Participates in Disaster recovery plan
  • Participates in pre-purchase evaluation programs & contract negotiations
  • Provides technical consultation to department and other personnel
  • Performs evaluation of equipment failures to identify trends, design and/or use problems

PHYSICAL AND SENSORY REQUIREMENTS:
Requires standing for up to eight hours a day or walking for up to four per day. Sitting for extended periods of time. Frequent fingering, handling and twisting and turning in using hand tools or other situations. Lifting and carrying items weighting up to 60 pounds. Occasional pulling and pushing objects weighing greater than 300 pounds. Climbing vertical ladders up to 20 feet. Seeing as it relates to normal vision, and hearing as it relates to normal hearing. Sense of smell as it relates to distinguishing burning or other odors when working on equipment.
EDUCATION:
Associate's Required. Bachelor's degree (preferred) in related field. An equivalent combination of education and experience may be substituted if approved.
TRAINING AND EXPERIENCE:
Five years' experience as a Senior Level Technician or Leader. Five unique device classes of formal training with certificate. Five projects as a Key Contributor / Lead Tech Leadership fundamentals class. Anatomy and Physiology knowledge. Financial report & auditing knowledge
Supervisory experience preferred.
Please complete your application using your full legal name and current home address. Be sure to include employment history for the past seven (7) years, including your present employer. Additionally, you are encouraged to upload a current resume, including all work history, education, and/or certifications and licenses, if applicable. It is highly recommended that you create a profile at the conclusion of submitting your first application. Thank you for your interest in St. Luke's!!
St. Luke's University Health Network is an Equal Opportunity Employer.

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