Note The job is a remote job and is open to candidates in USA. Heraeus Electro-Nite is a family-owned global technology leader dedicated to driving innovation across key industries. They are seeking a Design Assurance & Quality Engineer to lead product development, manage design controls, and ensure quality compliance in the medical device sector. Responsibilities Lead and implement product development, including the application of design controls, for new products and existing product changes including line extensions Create and maintain the design history file (DHF), including development of related specifications such as user requirements and design specifications Plan, implement, and report on design verification and validation studies, including bench and pre-clinical test protocols and reports Lead the development of manufacturing documentation and manufacturing process validation activities Responsible for risk management activities from product concept through commercialization Partner with Regulatory to support submissions for pre-market authorizations in the US Work closely with contract manufacturers and other suppliers to implement new projects and ensure supply chain meets performance and quality requirements Perform lot release, including reviewing batch records, device history records (DHRs), and process documentation for accuracy and completeness Support the intake, evaluation, and documentation of nonconforming materials Support post-market phase including product complaint handling, risk management, and post-market surveillance activities Help conduct supplier qualification and performance evaluation activities Communicate quality issues to suppliers and support resolution tasks Assist with internal audits and support external audits and inspections (e.g., FDA, ISO) Participate in CAPA investigations and track CAPA progress through verification of effectiveness Help provide QMS training and subject matter support for fellow employees Administer user set up and employee training in QMS support software and monitor training Serve as document control coordinator in QMS support software Identify opportunities to improve processes, reduce defects, and enhance overall product quality Monitor and trend quality metrics and escalate signals Skills Bachelor's degree in life sciences, material sciences, engineering or a related field required Experience in medical device industry required; minimum 3 years preferred Working knowledge of design controls and general knowledge of the ISO 13485 standard; formal ISO 13485 training is a plus Experience in a small company or start-up environment preferred Experience with QMS support software / document control systems is a plus Company Overview How do steel makers save energy and become more sustainable? How do foundries become more efficient and optimize their processes? Heraeus Electro-Nite (HEN) provides solutions for the molten metal industry. It was founded in 1933, and is headquartered in Houthalen, Limburg, BE, with a workforce of 1001-5000 employees. Its website is https//www.heraeus-electro-nite.com/.