Christian Brothers University

What you'll study

The credential requires completion of three graduate-level courses. Coursework concentrates on quality assurance, regulatory frameworks, healthcare packaging and quality systems necessary for the design, manufacture and evaluation of medical devices.

• ENGM 605 Quality Assurance (3 credits) — statistical quality control methods, design of quality control systems and control of quality-control inputs; lecture and problem solving.
• ENGM 643 Healthcare Packaging (3 credits) — materials used in healthcare packaging, materials selection, packaging design and conversion processes, aseptic packaging and sterilization considerations, storage and distribution, product coding for traceability, and steps for FDA validation planning and receiving.
• ENGM 650 Regulatory Affairs and Quality Systems (3 credits) — foundational understanding of regulatory affairs and quality systems for medical devices to improve cross-functional processes and efficiency.
• ENGM 652 Quality Systems for the Medical Device Industry (3 credits) — focused on quality systems specific to medical device manufacturing and oversight.

Entry requirements

Applicants must submit a graduate program application (select Graduate, Graduate Special/Non-Degree Seeking, indicate pursuing a certificate and choose the preferred certificate), an official undergraduate transcript showing a bachelor’s degree awarded, and a current résumé/CV.

Career prospects

The certificate prepares graduates for roles that support safe, effective and compliant medical device products reaching the market. Typical positions include Quality Systems Specialist, Regulatory Affairs Associate, Quality Assurance Manager, Medical Device Design Engineer, Compliance Analyst, Packaging and Reliability Engineer, Product Development Coordinator and Manufacturing Quality Engineer. The credential can aid advancement within a current employer or transition into quality and compliance functions across device manufacturing and health-technology firms.

Scholarships & funding angle

The program page does not list specific scholarships. Prospective students should check CBU’s graduate financial-aid resources, employer tuition-benefit policies, and continuing-education funding options to identify support for certificate coursework.