We are seeking applications for an experienced Senior Design Quality Engineer for our Clients Pharmaceutical & Medical Device Manufacturing site in Dublin.
In this role you will be a technical authority in the development and deployment of the convergent technologies needed to bring new and innovative products to market. You will be responsible for design control compliance, and product risk management. The role conducts all activities in compliance with regulatory and company procedures.
 
Why you should apply:

• The company is dedicated to diversity and inclusion and diversity, a culture empowering all people.
• A global focus, ensuring continuous investment in people and portfolio.
• They are an industry leader with a start-up mentality, but long history spanning more than 150 years.

 
What you will be doing:

• 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 needs.

• Bachelor degree in science, microbiology, engineering or equivalent technical field with 5+ years’ experience
• 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