Senior Quality Engineer

2 weeks ago

Dublin, Ireland Fire1 Full time

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Do you want to help improve the lives of millions of people?
We are developing cutting edge technology to reinvent the treatment of heart failure globally.
If you are interested in joining a dynamic team that is working hard to change the world for the better, we'd love to talk to you.
As a
Senior Quality Engineer
, 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
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
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
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