Location: Dublin
Description
As a Quality Engineer at FIRE1, you will support the execution of the Quality Management System (QMS) with primary responsibility being to support the quality team. Support manufacturing, supply chain and design assurance activities. Represent the quality function cross functionally.
Responsibilities
- Support the day to day implementation of the QMS
- Support QMS continuous improvement activities
- Quality liaison with suppliers on supplier performance and driver of quality related component issues to resolution
- Support continuous improvement of supplied material inspection process and procedures
- Development of quality procedures and work instructions in support of the QMS
- Trending and reporting of quality metrics and key performance indicators
- Support with internal and external audits
- Support manufacturing team activities associated with manufacturing in a regulated environment e.g. equipment qualification and change control
- Engagement with various stakeholders including suppliers and regulatory authorities as required
- Ad hoc duties as required
Qualification & Experience
Essential:
- Bachelor’s Degree in Engineering, Science or related field
- 2+ years’ experience in medical device quality/design assurance roleExceptional attention to detail
- Excellent communicator
- Well organised and ability to work under pressure and meet deadlines
- An aptitude for identifying & implementing process improvements
- Knowledge of quality systems and principles, especially ISO 13485
- Proven ability to function efficiently in a fast-paced environment with multiple and shifting priorities
- Ability to think analytically and problem solve proactively
Desirable:
- Experience in implantable medical devices
- Recent regulatory experience including FDA regulations, ISO 13485 and other applicable national/ international regulations and standards
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)?