Graduate Certificate in Quality of Medical Devices

Prepare for advancing your expertise in medical device engineering and quality systems with CBU’s Graduate Certificate in Quality of Medical Devices. This professional certificate in medical device quality is designed for professionals in or entering the medical equipment and medical devices industry, helping you develop practical skills aligning with current industry standards. 

What You’ll Study

The certificate in medical device engineering requires the completion of three graduate-level courses. Coursework focuses on quality assurance, regulatory frameworks, healthcare packaging, and quality systems that are essential to the design, manufacture, and evaluation of medical devices. Students may complete classes online, on campus, or through a combination of both formats, offering flexibility for working professionals. 

The flexible structure of this quality control medical devices certificate allows you to tailor your studies while building competencies that apply to your career profession or future graduate study, with all classes able to be applied towards the MS in Computer Information Systems (MSCIS) or the Master of Science in Engineering Management (MSEM) program upon successful completion.

Career Opportunities 

Earning a certificate in quality of medical devices can position you for a range of career pathways in the medical devices and healthcare technology sectors. With specialized training in quality systems, regulatory compliance, and packaging considerations, graduates are prepared to contribute to roles that help ensure safe, effective, and compliant products reach the marketplace. 

Potential career opportunities include:

• Quality Systems Specialist 
• Regulatory Affairs Associate 
• Quality Assurance Manager 
• Medical Device Design Engineer 
• Compliance Analyst 
• Packaging and Reliability Engineer 
• Product Development Coordinator 
• Manufacturing Quality Engineer 

This graduate credential in medical devices supports professionals seeking to advance within their current organization or transition into quality and compliance roles across medical equipment manufacturing, health technology firms, and related sectors.

Skills You’ll Build

Through this quality control medical devices certificate, you’ll develop a skill set that reflects what employers in the medical devices industry value most: 

• Understanding of Quality Systems – Interpret and apply industry standards such as FDA and ISA requirements. 
• Regulatory Knowledge – Navigate regulatory frameworks affecting product approval and compliance. 
• Quality Assurance Techniques – Use statistical and systematic approaches to ensure product consistency and performance. 
• Healthcare Packaging Insight – Assess packaging materials and design for product protection and regulatory alignment. 
• Cross-Functional Collaboration – Communicate effectively with engineering, manufacturing, and regulatory teams. 
• Problem Analysis and Solution Design – Apply critical thinking to diagnose quality issues and implement corrective actions. 

These competencies help prepare you for leadership and technical roles in medical device engineering.

How to Apply

To apply, submit the following:

1. Graduate Program Application 

• Select Graduate for Application Type 
• Select Graduate Special/Non-Degree Seeking for Student Type 
• Select “Yes” to indicate you will pursue a certificate 
• Select the preferred graduate certificate program 

2. Official college/university transcript showing bachelor’s degree awarded

3. A current resume/CV