Location: Dublin, Ireland
Reports to: Quality Systems Manager
Role Purpose:
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.
Knowledge & Education:
- Essential
- Bachelor’s Degree in Engineering, Science or related field
- 3+ 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 with implantable medical devices
- Experience with process development and change management in regulated environment
Competencies & Experience:
- Exceptional attention to detail
- Excellent communicator
- Well organised with ability to work to deadlines
- An aptitude for identifying & implementing process improvements
- Ability to proactively identify issues and make recommendations
- Proven ability to function efficiently in a faced-paced environment with multiple and shifting priorities
- Have strong multi-tasking skills
Responsibilities/Key Objectives:
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 investigationsAd hoc duties as required.
