A leading Waterford based Medical Device organisation currently has a requirement for an experienced Quality Engineer to assist in the development and implementation of quality plans, programs and
procedures using quality control statistics, lean manufacturing concepts, and analyses.
- Support release of assembly batches including offline testing, paperwork, and stratified samples management.
- Update and creation of work instructions as required.
- Support of validation and metrology activities.
- Drive changes in process to minimise risk of error in paperwork, sampling or testing.
- Work with team leader, QA Inspectors, line Co-ordinators and batch release specialist to ensure all steps of batch completion and release are defined and executed consistently.
- Be point of co-ordination for all quality issues between automation and moulding.
- Set-up process to log, track and resolve issues seen.
- Drive specific issues to resolution.
- Determine opportunities to pro-actively drive product quality improvement though process or procedural changes.
- Support all company safety and quality programs and initiatives.
- Ensure ongoing compliance with GMP in all practices, recording of events and processes.
- Ensure compliance with all learnings from all GMP training events.
- Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.
- Level 8 Degree in Science / Engineering (Mechanical / Electronics / Chemistry) or related discipline. Or Level 7 in same disciplines coupled with 2/3 years relevant quality experience in a GMP environment.
- Excellent IT, Communication, Interpersonal and presentation skills
- Ability to work off own initiative and as part of a cross functional team.
- Desire to learn new tasks
- Performance and results driven
For a confidential discussion and more information on the role, please contact Kevin Griffin