Quality engineers for medical devices are responsible for all aspects of quality assurance in the design and production of medical device products. They must design and implement tests that effectively, efficiently monitor the quality of the medical device in each stage of the production process. Due to the vital nature of the medical device field, quality engineers for medical devices must adhere to strict guidelines for quality and risk. Quality engineers work with clients, other internal departments, and regulatory agencies to establish precise requirements for new product standards. They then design and test the new product at various stages of the production process to ensure these standards are met. They periodically review older testing standards to ensure they meet current industry and client requirements. Once tests are completed, quality engineers provide feedback to design engineers on how to improve quality and meet product specifications as necessary.
Quality engineers work in a mix of environments, including laboratory and manufacturing areas. They work a standard 40-hour week. They spend much of their time designing and implementing testing procedures, with the rest of their time spent giving testing results analysis and gathering feedback from clients and regulators on specification details.
Quality engineers for medical devices are required to hold a bachelor’s degree in engineering, a life science field, medical technology, or a related discipline. Experience in the quality control field, especially in the relevant industry, is also required. Certification by quality assurance or project management agencies may be necessary for certain positions.
Quality Engineer, Medical Devices Tasks
Support new product development for design and quality related functions.
Initiate standards and methods for inspeciton, testing, and evaluation.
Responsible for product maintenance.