Senior Quality Assurance Engineer
4 days ago
Direct message the job poster from Mason Alexander
We are delighted to be partnering with an exciting Medical Device company based in Dublin, on a permanent Senior Quality Engineer position.
This role will be a significant contribution to this company in a pivotal stage of their growth and will focus on driving the day to day implementation of the QMS with a focus on continuous improvement. You will support manufacturing, supply chain and design assurance activities and represent the quality function cross functionally.
As Senior Quality Engineer, your responsibilities will include:
- Drive the day to day implementation of the QMS
- 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
- 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
Education & 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
This role is based on-site in Dublin, current working arrangements are 4 days onsite and 1 day from home per week.
This is a fantastic opportunity to join a hugely successful company at an exciting time in their development and significantly contribute to their growth
Seniority levelMid-Senior level
Employment typeFull-time
Job functionQuality Assurance, Manufacturing, and Science
IndustriesMedical Equipment Manufacturing, Hospitals and Health Care, and Pharmaceutical Manufacturing
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