Job Description
Why Us? With a mantra of Empowering Human Potential, Hanger, Inc. is the world's premier provider of orthotic and prosthetic (O&P) services and products, offering the most advanced O&P solutions, clinically differentiated programs and unsurpassed customer service. Hanger's Patient Care segment is the largest owner and operator of O&P patient care clinics nationwide. Through its Products & Services segment, Hanger distributes branded and private label O&P devices, products and components, and provides rehabilitative solutions to the broader market. With 160 years of clinical excellence and innovation, Hanger's vision is to lead the orthotic and prosthetic markets by providing superior patient care, outcomes, services and value. Collectively, Hanger employees touch thousands of lives each day, helping people achieve new levels of mobility and freedom. Could This Be For You? The Quality Assurance Engineer has the responsibilities to coordinate and perform quality assurance and product development activities according to medical device regulations of 21 CFR 820 and/or ISO 13485:2016, Medical Device Directive (MDD), ISO 13485, and ISO 14971. QA Engineer will be responsible for managing incoming inspection and product release activities. This includes ensuring incoming and final release products meet specifications and QA requirements. The duties will also include document control management, management of CAPA activities, product review investigations. QA Engineer will work with Product Development to ensure that design control process is followed for new and existing product lines. Your Impact Implement QA/QC activities according to the requirements of 21 CFR 820, ISO 13485:2016, and CE mark during design, manufacturing, and product fulfillment process. Perform incoming inspections, final product release inspections, and preliminary product failure investigation/testing as a part of CAPA process.<