About the roleAs Design Assurance QE you will be involved in new product development and product sustaining projects through the application of Quality engineering skills. You will handle multiple projects and tasks, from product inception through product launch and maintenance, utilising a high level of written and oral communication skills.Main responsibilitiesBe the Design Assurance Quality Engineer on project core teams for design change projects and develop close relationships with other quality functions as needed for the project.Write project quality plans and support the creation and maintenance of DHF documentation.Lead risk management activities within the project.Support the creation and implementation of verification and validation activities.Review and approve test protocol and reports.Review and challenge statistical rationale and data analysis in the frame of test protocol and reports.Review and approve related execution deviations.Assist / conduct failure investigations and problem‑solving sessions.Review quality objectives and goals that have been identified and ensure they are sufficiently defined in specifications, procedures, and testing.Conduct quality functional reviews and DHF compliance reviews.Ensure compliance across projects for design control, risk management, and change control processes.Support Quality culture within the R&D organisation while providing training on applicable requirements / standards.About youA relevant degree (engineering degree preferred) or equivalent experience; minimum 3 years of quality engineering experience.Knowledge in working with ISO 13485, QSR, ISO 14971, statistical techniques.Strong written and verbal communication skills.Strong organisational skills.Experience with MDR (advantage).Experience with IEC62304 and IEC62366 (advantage).SalarySalary Range €55K - €70KEqual Opportunity StatementBecton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
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