Our client, a mid sized SaMD, is seeking an experienced Design Quality Engineer to own a number of NPD activities. The role offers a fast-paced team environment where you can make an impact in a particularly vulnerable demographic.ResponsibilitiesLead Design control activities for a number of their NPD including DHF and DFMEAWrite brand new risk management filesDevelop new V&V testingSupport with cybersecurity activitiesBe part of a team supporting wider range quality activities including post marketing, CAPAs and auditQualificationsExperienced within design/risk activities for SaMD (i.e. both a ISO13485 and IEC 62304 background)Hands on Design History File (DHF) writing alongside Design control activities including V&V planning, DFEMA and risk management writingWorked in Agile environments and SDLCIdeal candidates would have worked with cybersecurity standards (ISO 27001)Bachelor's degree requiredDetailsSeniority level: Mid-Senior levelEmployment type: Full-timeJob function: Quality Assurance, Manufacturing, and DesignIndustries: Medical Equipment Manufacturing and Software Development
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