[Remote] Design Assurance & Quality Engineer

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.ResponsibilitiesLead and implement product development, including the application of design controls, for new products and existing product changes including line extensionsCreate and maintain the design history file (DHF), including development of related specifications such as user requirements and design specificationsPlan, implement, and report on design verification and validation studies, including bench and pre-clinical test protocols and reportsLead the development of manufacturing documentation and manufacturing process validation activitiesResponsible for risk management activities from product concept through commercializationPartner with Regulatory to support submissions for pre-market authorizations in the USWork closely with contract manufacturers and other suppliers to implement new projects and ensure supply chain meets performance and quality requirementsPerform lot release, including reviewing batch records, device history records (DHRs), and process documentation for accuracy and completenessSupport the intake, evaluation, and documentation of nonconforming materialsSupport post-market phase including product complaint handling, risk management, and post-market surveillance activitiesHelp conduct supplier qualification and performance evaluation activitiesCommunicate quality issues to suppliers and support resolution tasksAssist with internal audits and support external audits and inspections (e.g., FDA, ISO)Participate in CAPA investigations and track CAPA progress through verification of effectivenessHelp provide QMS training and subject matter support for fellow employeesAdminister user set up and employee training in QMS support software and monitor trainingServe as document control coordinator in QMS support softwareIdentify opportunities to improve processes, reduce defects, and enhance overall product qualityMonitor and trend quality metrics and escalate signalsSkillsBachelor's degree in life sciences, material sciences, engineering or a related field requiredExperience in medical device industry required; minimum 3 years preferredWorking knowledge of design controls and general knowledge of the ISO 13485 standard; formal ISO 13485 training is a plusExperience in a small company or start-up environment preferredExperience with QMS support software / document control systems is a plusCompany OverviewHow 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/.