Senior Design Assurance Engineer- Start-upPermanentGalwayJOB DESCRIPTIONPosition: Senior Design Assurance EngineerThe role of Senior Design Assurance Engineer is to act as the Quality Assurance technical and compliance expert as part of a cross‑functional team for the design and development of sterile and non‑sterile medical devices and subsequent design changes. This role ensures compliance with applicable regulatory and quality requirements including ISO 13485, FDA 21 CFR Part 820 (QMSR), and relevant international regulatory standards.Device testing and associated validationsInternal and external audits; acting as SME for design processesGeneration and/or approval of technical documentation on behalf of the Quality functionDesign History File (DHF) managementContinuous improvement of the Quality Management System (QMS)Key ResponsibilitiesEnsure compliance of product development and risk management activities with internal quality procedures and applicable regulatory requirements.Work effectively as part of a product development team to translate user needs into design requirements, identify critical design features and components, and lead or contribute to risk management and quality documentation.Plan, execute, and document design verification, design validation, and test method validation activities.Collaborate with R&D and Manufacturing Engineering to translate design requirements into manufacturing requirements, including development of manufacturing test methods and implementation of process monitoring activities.Lead resolution of project quality issues by applying systematic problem‑solving methodologies in collaboration with internal teams, suppliers, and external partners.Monitor compliance with quality systems and regulatory requirements, identifying and implementing process and system improvements.Apply, recommend, and develop quality tools and statistical techniques to support product development, manufacturing, and commercialisation activities.Represent the organisation professionally with external agencies, vendors, and regulatory bodies.Other responsibilities include (but are not limited to):Lead and support compliance and continuous improvement activities associated with the Quality Management System (e.g. CAPA, audit programs, training).Participate in departmental activities in accordance with internal procedures and external regulations.Plan, execute, report, and follow up on quality system audits; act as audit escort and support regulatory inspections as required.Make decisions aligned with management objectives to achieve quality goals related to processes, schedules, and deliverables.Track and report progress across projects and departmental commitments, identify risks, and support contingency planning.Generate, review, and approve operational, test, and validation data for equipment, materials, components, sub‑assemblies, and finished products.Provide technical quality guidance and mentoring to engineers, technicians, and inspection staff.Act as system administrator for statistical analysis tools (e.g. Minitab).Ensure compliance with the Quality Manual and applicable QMS procedures.Bachelor's degree in Engineering, Science, or a related technical discipline.Minimum of 6 years' QA, Quality Systems, or Regulatory experience within the medical device industry.Strong experience supporting product design and development activities within a regulated environment.In‑depth knowledge of ISO 13485:2016, FDA 21 CFR Part 820 (QMSR), European MDR, Canadian Medical Device Regulations, and other international standards.Experience preparing for and supporting notified body and FDA inspections.Strong organisational skills with the ability to manage multiple priorities in a fast‑paced environment.Excellent written and verbal communication skills with proficiency in MS Office tools.Strong problem‑solving, decision‑making, and risk‑based thinking abilities.Highly motivated, self‑directed, and collaborative team player with good business acumen.
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