Location: Dublin
Description
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
- 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
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