As a
Senior 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.
Responsibilities
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
Qualification & Experience
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 *****, 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
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:
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?
Are you legally authorized to work in Ireland, and would you require sponorship (now or in the future)?
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