Senior Design Quality Engineer
Job ID: JOB-11853
SENIOR DESIGN QUALITY ENGINEER
Our Client, a global leader in Pharmaceuticals are seeking to attract a Senior Design Quality Engineer for their site in Dublin, who will be responsible for the development and deployment of the convergent technologies needed to bring new and innovative products to market. The ideal candidate will have experience in design control compliance, and product risk management. The position will report to the Design Quality Manager and is commutable from Meath and Kildare.
- 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
- 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
- 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 role in please contact Mark Wilson on 0860449473 or email firstname.lastname@example.org
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