Senior Quality Engineer

As aSenior Quality Engineer at FIRE1, you will drive the day-to-day implementation and maintenance of our Quality Management System (QMS), with a strong emphasis on continuous improvement. You will provide quality support with a focus on our manufacturing and production activity. You will act as a cross-functional representative of the Quality team, driving collaboration and alignment across departments.

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• Support manufacturing team activities associated with manufacturing in a regulated environment e.g. equipment qualification, process validation, continuous improvement and change control
  
• Support supply chain in supplier related activities e.g. process development and manufacturing requirements
  
• Develop and review test specifications, part specifications & design specifications with cross functional team
  
• Ensure delivery of overall quality strategy & support achievement of the business quality objectives
  
• Collaborate with wider team to ensure necessary QA activities are planned, executed and documented
  
• Drive the day-to-day implementation of the QMS
  
• Interpret relevant standards and ensure company meets requirements
  
• Provide practical QA and Design Assurance expertise
  
• Coordinate and manage key activities such as internal audit programme, material review board, NC/CAPA review board, complaint process
  
• Project support for regulatory submissions
  
• Support clinical investigations
  

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• Recent manufacturing support experience in a regulated environment
  
• Bachelor’s Degree in Engineering, Science or related field
  
• 5+ years’ experience in medical device quality/design assurance role
  
• Recent regulatory experience including FDA regulations, ISO 13485, Medical Device Directive and other applicable national and international regulations and standards
  
• Exceptional attention to detail
  
• Excellent communication and influencing skills – good listener
  
• Ability to work under pressure and meet deadlines
  
• An aptitude for identifying & implementing process improvements
  
• Target driven individual who can work to own initiative
  
• Ability to think analytically and problem solve
  
• Master’s degree in Engineering, Science or related field
  
• Experience in implantable medical devices
  
• Experience with process development and change management in regulated environment
  

Reporting

This role reports to the Quality Systems Manager

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• 25 days annual leave
  
• Competitive health insurance plan with VHI
  
• Pension 8% employer contribution
  
• Employee share ownership programme
  
• Discretionary bonus plan
  
• Discounted gym membership at DCU & UCD gyms
  
• Taxsaver Commuter Tickets & Bike to Work Scheme
  
• EAP (Employee Assistance Programme)
  
• Employer funded Sports & Social Committee
  

To apply for this role please click below or email your CV to .

Also include answers to the following questions:

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• How many years of Quality experience do you have in a regulated environment?
  
• How much experience do you have directly supporting a manufacturing production line? xcfaprz
  
• Are you legally authorized to work in Ireland, and would you require sponorship (now or in the future)?