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Thomas Gallagher
Life Science

+353870612325
[email protected]
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Details

Senior Quality Engineer


Reference:TG - SQE - Dublin Location: Dublin
Dublin City Centre
Dublin Greater
Dublin North
Dublin South
Dublin West
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Design Assurance, Lead Quality Engineer, QA Engineer, QA RA Engineer, QA Specialist, QA Validation Specialist, QE Manufacturing Engineer, Quality Engineer

Job title: Senior Quality Engineer
Location: Glasnevin, Dublin 11 (on site role)
Benefits: Top salary, Bonus, pension and Healthcare

Company:
My client 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 drive the day to day implementation of the QMS with a focus on continuous improvement. Support manufacturing, supply chain and design assurance activities. 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:
- 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


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 [email protected]