Job title: Senior Quality Engineer
Location: Glasnevin, Dublin 11
Benefits: Top salary, Bonus, pension and Healthcare


Company:
An exciting time for my client who are currently running clinical trials across Europe and the US, in collaboration with leading researchers and scientists who share our commitment to transforming the lives of the millions of people living with heart failure. They have a diverse team who respect each other’s opinions and work and learn together in an open and honest way to achieve their ambitious purpose.


Job Overview:
To support manufacturing team activities associated with manufacturing in a regulated environment. Drive the day to day implementation of the QMS with a focus on continuous improvement. Represent the quality function cross functionally.


Experience required:
- 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


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


Does this sound like your next career move? To apply and for more info forward your application to the link provided or contact me on 087 0612325 OR thomas.gallagher@lifescience.ie