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Career as a Certified Biomedical Auditor (CBA)

Are you looking forward to become a Certified Biomedical Auditor? Then it is important to have a clear idea about how it is to be a Certified Biomedical Auditor. In addition to that, you must also have a clear understanding about what you have to do as well. Then you can make an informed decision to proceed to the next step. This article will provide all the information that you need to know before you become a Certified Biomedical Auditor.

What is a Certified Biomedical Auditor (CBA)?

The main responsibility of a Certified Biomedical Auditor is to audit biomedical systems that exist out there. In order to do that, you need to have a clear understanding about the regulations, standards, guidance and directives needed for auditing biomedical systems. You will be using a variety of tools to proceed with the audit as well. Likewise, numerous other techniques will also be used in order to examine, evaluate, question and report the deficiencies and adequacies that exist within the system.

While working as a Certified Biomedical Auditor, it is important to inspect all the elements associated with the system. After the analysis, the CBA should prepare a report. This report should contain information on how the system adheres to the criteria defined by the management to ensure process safety.

Following are some of the most prominent responsibilities that you will have to fulfill in your day to day work routine.

    • Understand and apply appropriate quality management techniques to the biomedical quality management systems. They include International Standards for Quality such as ISO 12485 and ISO 9001.
    • Undertake different types of responsibilities and audits with related to the biomedical systems.
    • Understand the key elements that are associated with software development lifecycle and learning how to ensure quality control with it.
    • Understanding the bio-compatibility terms along with the guidelines and standards that are applicable. Evaluate the environmental factors and figure out whether utilities are in need of maintenance, validation or qualification.
    • Understanding the risk management programs and the requirements that are needed to have for medical device reporting, vigilance and compliant handling. Going through the validation procedures on a regular basis and reviewing them.
    • Discovering the standards that are associated with hazard detection, risk management and sterilization.
    • Discovering the quality tools that can be used, such as Pareto Charts, check sheets, statistical process control charts, histograms and scatter diagrams.

The Certified Biomedical Auditors are adding lots of value to companies that exist out there as well. For example, you will be able to make sure that compliance with regulations and conformity to the industry standards are met by the biomedical systems that are in place.

Along with the regular audits that you do, you will get the opportunity to overcome expensive risks that can take place in the future. That’s because you will provide recommendations to the appropriate sterilization methods and techniques that can be used. Along with your support, it is possible to improve the processes. That’s because you will be implementing appropriate techniques and tools within a company to enhance the quality of the systems.

How to become a Certified Biomedical Auditor?

You will need to have five years of full-time work experience to become a Certified Biomedical Auditor. Out of them, you should have worked for a decision making role at least for one year. However, there is a possibility to get the number of years of work experience that you have based on your educational qualifications.

It is important to have a degree obtained from a university, college or a technical school to start working as a Certified Biomedical Auditor without having any work experience. In fact, you will be able to get four years of work experience waived off by completing a doctorate degree or a master’s degree. If you have a bachelor’s degree, three years can be waived off. Likewise, an associate’s degree can help you to waive off one year.

You should also obtain a certification to start working as a professional. There are some important textbooks, which you need to refer to, so that you can get assistance with obtaining the certification. Those books include The Biomedical Quality Control Handbook and the Biomedical Division books as well. After obtaining the certification, you will have to renew it every three years.

How much does a certified biomedical auditor (CBA) earn?

It is worthy to have a clear understanding in your mind about the amount of money that a Certified Biomedical Auditor is making per year. An average Certified Biomedical Auditor would earn around $91,000 per year by working for a company. If you don’t have a certification, you will only be able to earn around $72,000. That’s why it is important for everyone working in this industry to obtain the certification. You must also keep in mind that the salary that you can get would increase along with your special skills and years of experience within the industry.

Certified biomedical auditor (CBA) Jobs?

As a Certified Biomedical Auditor, you are provided with numerous job positions to take place within the industry. Some of the most prominent job titles that you can perform are as follows:

    • Quality audit manager
    • Project manager
    • Biomedical engineer
    • Biomedical auditor
    • Regulatory manager
    • Regulatory expert
    • Quality manager
    • Supplier quality engineer

It is up to you to take a look at the specific job descriptions and get into the best job as per your preferences.


Now you have a clear picture on what you will be able to get after you become a Certified Biomedical Auditor. If you are impressed with the experiences that you have to go through, you will be able to go ahead and become a Certified Biomedical Auditor without keeping any doubts or second thoughts in mind.