Senior Quality Engineer

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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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