The quality of medical devices and drugs is a prominent issue in healthcare, science, business, government, and among the public. Federal laws and healthcare professionals in the United States and countries around the world require that medical devices and drugs are safe, effective, and reliable.

The FDA has added design guidelines that suggest quality engineers should specify the purpose of each feature a medical device needs to have at the beginning of the design process. The new guidelines continue to increase the need for biomedical quality engineers.

Due to the need for monitoring the quality of medical technology as medical companies invent, develop, and market medical products, there are many types of careers in medical quality, and all of them have important responsibilities.

In a device design guidance document, the FDA says, "Those persons in medical device companies charged with responsibility for developing, implementing, or applying design controls come from a wide variety of technical and non-technical backgrounds--engineering, business administration, life sciences, computer science, and the arts."

Biomedical quality involves these industrial job categories from The U.S. Department of Labor's Occupational Outlook Handbook:

Employees with experience in medical quality can hold a range of positions, from entry level technicians to corporate executive officers. The sizes of companies that employ medical quality specialists range from one-person consulting companies to some of the world's largest companies.

The U.S. Department of Labor's Occupational Outlook Handbook (2004-5 Edition) says that the median income for biomedical engineers was $60,410 in 2002. The top10 percent of biomedical engineers earned more than $107,520. Biomedical engineers with a bachelor's degree started, on the average, with a $39,126 salary. Engineers starting with a master's degree received, on the average, a salary of $61,000.

Medical quality specialists have demanding responsibilities.

Safety. In research, development, manufacturing, and marketing, medical quality specialists help identify the unwanted side effects a medical device or drug might have. Medical quality specialists help solve unusually dangerous side effects, and they coordinate recalling a product if it fails.

Reliability. Medical quality specialists determine that medical products work properly, and that they have enough strength and durability.

Effectiveness. Medical quality specialists conduct clinical studies involving physicians and patients to show that medical products solve medical problems effectively.

In their jobs, medical quality specialists evaluate the purity, strength, and durability of materials, such as metals, chemicals, biological materials, silicone, and adhesives. They organize clinical trials at hospitals and clinics, where doctors report how new products help their patients. They monitor the environmental quality of clean rooms where assemblers manufacture implantable medical products and drugs. And they evaluate sterile medical packaging and materials.

While qualified engineers and technicians from any engineering or scientific field can work in medical quality, a few colleges and universities offer specialized programs to educate biomedical engineers and technicians.

Biomedical engineers fulfill a four-year engineering program in college, taking courses in mathematics, chemistry, biology, cell biology, physiology, biomechanics, biomaterials, and biomedical engineering design. Engineering technicians can fulfill the requirements for a two-year associates degree and finish courses in biology, engineering and medical technology. Leading technical colleges around the United States are also teaching management of technology programs for drugs and biological products.