Senior Design Quality Engineer
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
- 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/ email@example.com
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