Job Description
**Senior Design Assurance Engineer** A highly skilled Senior Design Assurance Engineer is required to lead the design control and risk management activities for a medical device client in Galway, Ireland. **Job Description** Under limited supervision, this position is responsible for ensuring design control and risk management activities comply with federal, state, and local laws, procedures, and guidelines. The successful candidate will provide quality support and guidance to R&D projects, lead and support design assurance engineers and quality engineers, and coordinate resources to support business objectives. **Key Responsibilities:** • Ensure design control and risk management activities comply with regulatory requirements • Provide quality support and guidance to R&D projects • Lead and support design assurance engineers and quality engineers • Coordinate resources to support business objectives • Resolve project issues through collaboration with team members, suppliers, and others • Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues • Manage and maintain records related to design control projects • Contribute to design review meetings • Provide input into the generation of risk management file documents • Develop protocols and reports supporting the design control process • Review and approve production records and sterilization records • Support bench test activity as required • Translate design requirements into manufacturing requirements • Monitor data from quality management systems and provide feedback to quality management • Administer and manage systems for CAPA, non-conformances, and supplier corrective actions • Lead and facilitate compliance and improvement activities associated with the quality system • Prepare data for management review • Act as an audit escort and support coordination of backroom activity during inspections • Support internal and supplier audits • Support regulatory activities as requested by management • Compile and conduct quality system training for employees **Requirements:** • Minimum degree in a technical field • Minimum 5 years' experience in the medical device industry or IVD/pharmaceutical • Demonstrated knowledge of design control, sterilization, and quality assurance processes • Experience in preparation, participation, and response to external agency inspections • Thorough knowledge of design control requirements and processes • Working knowledge of 21 CFR 820, ISO 13485, and other foreign medical device quality system requirements • Ability to handle multiple projects simultaneously and discern major quality issues • Ability to work well under deadlines and pressure • Ability to work on own initiative and as a team player • Ability to build good working relationships with cross-functional teams internationally • Ability to communicate clearly, accurately, and directly to a widely varied audience