Location: Dublin
Description
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
- Lead QMS continuous improvement activities
- 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
Essential:
- 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 13485, 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
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
To apply for this role please click below or email your CV to careers@fire1foundry.com.
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)?