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
* Lead QMS continuous improvement activities
* 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
Essential:
* 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
Desirable:
* 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
Benefits:
* 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