The Design Assurance Quality Engineer works on new product development and product sustaining projects, applying quality engineering skills across the product lifecycle. The role requires managing multiple simultaneous projects, communicating effectively in writing and orally, and ensuring products meet quality and compliance standards in line with corporate, global, and regulatory requirements.ResponsibilitiesBe the Design Assurance Quality Engineer on project core teams for design change projects and develop close relationships with other quality functions as needed.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 protocols and reports.Review and challenge statistical rationale and data analysis in the context of test protocols and reports.Review and approve related execution deviations.Assist or conduct failure investigations and problem‑solving sessions.Review quality objectives and goals 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 organization while providing training on applicable requirements and standards.QualificationsCompleted a level 8 engineering degree in a relevant subject.3+ years experience in a quality engineering environment.Knowledge of ISO13485, QSR, ISO14971, and statistical techniques.Strong written and verbal communication skills.Strong organizational skills.Experience with IEC62304 and IEC62366 (advantage).Salary€55,000 – €65,000 per annum.LocationLimerick – Castletroy, Ireland.Becton, 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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