Job Description
Senior Design Assurance EngineerOur client, a medical device company, is currently seeking a Design Assurance Engineer to join their team. The Design Assurance Engineer will be working in the Quality Assurance/Regulatory Affairs department responsible for Medical Product (CE Mark and FDA 510k) Design Assurance, Design Controls, Product and Process Validation System, and Risk Management Activities.Role/Responsibilities:Performs Design Assurance activities including technical reviews of design documentation and labelling, attends design reviews, coordinates and facilitates completion and update of design risk management documentation, and acts as independent reviewer for all design activities including design changes.Project manager for EU MDR deliverables.Support MDR projects as deemed necessary by the QARA Department.Quality approver on all relevant records, tests, validations, reports, project file entries, etc.Supports external audits including notified body and FDA audits.Promotes the awareness of regulatory and customer requirements throughout the organization.Perform standards gap analyses as required for MDR, R&D projects, etc.QA lead for Product design transfer/validation strategy development and implementation.Provide guidance and training for new hires and student engineers.Support new test development and appropriate test method validation.Lead data analysis best practices including sample planning, reporting, and statistical analysis.Implement updates to applicable quality system requirements.Methodical review approach and be capable of initiating and leading change and continuous improvement.Education/Experience:A degree in Engineering, Technology, or Science.At least 5-7 years’ experience working in a regulated device or pharmaceutical company.Excellent planning and coordination skills.Excellent verbal and written communication skills.Must have attention to detail for this Quality role.Training in risk management, problem-solving methods, design controls, validations, usability, or biocompatibility would be advantageous.For further information, please contact James Cassidy at james.cassidy@lifescience.ie or call in confidence 086 0204322. #J-18808-Ljbffr