Senior Design Quality Engineer

My client are searching for a Senior Design Quality Engineer to join their team on a permanent basis at their Global Medical Device Engineering facility in North Dublin

Job Description

• Support new product design and development, design transfer, design validation, design review, risk management, etc. working closely with Device Engineering through the entire product life cycle.
• Design control compliance ensuring consistent, workable and compliant planning, development (inputs, outputs and review), testing (verification, validation and review), and change management;
• Regulatory compliance: ensuring product development and maintenance in accordance with FDA QSR’s (21 CFR Part 820), ISO 13485, CMDR, MDD, J-PAL and relevant guidance documents (FDA, etc)
• Design risk management, assuring appropriate and consistent risk management tool use i.e. FMEA, FTA, etc. for all programs and projects, compliant with regulatory standards (ISO/EN 14971) and industry practices,
• Supervision of and contribution to pre- and post- market risk assessments;
• Interact with other functions such as Global Design Engineering (GDE), Manufacturing, Regulatory, Product Monitoring, Clinical and Operations as necessary
• Perform internal and supplier audits
• This role may be required to lead personnel (inside and outside) the Quality organization in support of the business need
• Other tasks deemed necessary by the Design Quality Manager

Education, Experience And Competencies

• Bachelor degree in science, microbiology, engineering or equivalent technical field with 5+ years of applicable industry experience is required or a MS with 2+ years of applicable industry experience is required.
• Experience in medical device design control and product realization
• Experience in statistical tools including design of experiments and sampling methods
• Experience in design quality assurance, risk management
• Experience with root cause analysis and CAPA implementation
• Understanding one or more subsystem technologies: electrical, mechanical pneumatic and / or software systems
• Industrial microbiology experience including sterilization validation, environmental monitoring, Endotoxin testing, change assessments
• Experience in medical device biocompatibility assessments per ISO 10993 and other relevant standards.
• Understanding of human factor and user-interface design
• Understanding of medical device regulations including FDA, GMP, design controls, ISO 13485, EU MDR, IEC 62304, ISO 14971, etc.
• Lead auditor certification
• Excellent written, verbal and interpersonal communications skills are required.

For further information on this Senior Design Quality Engineer role in Dublin please contact Amanda Reynolds on 0860468858/ technical@hero.ie

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JOB-4089