Senior Quality Engineer

4 weeks ago

Dublin, Dublin City, Ireland FIRE1 Foundry Full time

You will lead the day-to-day implementation and maintenance of the Quality Management System (QMS), with a strong emphasis on continuous improvement. Provide quality support across manufacturing, supply chain, and design assurance functions. Act as a cross-functional representative of the Quality team, driving collaboration and alignment across departments.

Responsibilities
  • Drive the day to day implementation of the QMS
  • 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
  • Interpret relevant standards and ensure company meets requirements
  • Develop and review test specifications, part specifications & design specifications with cross functional team
  • Support manufacturing team activities associated with manufacturing in a regulated environment e.g. equipment qualification, process validation and change control
  • Provide practical QA and Design Assurance expertise
  • Support supply chain in supplier related activities e.g. process development and manufacturing requirements
  • 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
Qualification & Experience
  • Bachelor's Degree in Engineering, Science or related field
  • 3+ 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
  • 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

  • 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 careers@fire1foundry.com

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