Certificate in Quality for the Medical Device IndustryOpen for applications on www.gmit.ie
Location: Galway - Dublin Road
NFQ Level: 8
Programme Duration: One year
Mode of Study: Part time
Application Route: Apply direct to GMIT
Entry Requirements: Bachelor of Science (BSc) degree in Quality for Industry (Level 7), or equivalent
2,500 Euros (subject to confirmation) for the 40 credit Minor Award. 1,500 Euros for the remaining 20 credits.
- The aim of this programme is to provide you with the skills to play key roles in quality management and quality engineering within the medical device sector.
- You will cover key areas such as Regulatory Affairs, Quality Management and Operational Excellence.
- GMIT have collaborated with the local Medical Device sector to develop this programme which will deliver key skills within the Quality Engineering field.
- This programme has the support of a large number of indigenous and multinational-based Medical Device companies.
- It will be delivered in a flexible fashion in order to facilitate those working in the sector to also complete the programme.
Open for applications on https://apply.gmit.ie
- Statistics and experimental design - download module details here (PDF)
- Quality management systems & frameworks - download module details here (PDF)
- Technical writing with case studies - download module details here (PDF)
- Design Quality Assurance - download module details here (PDF)
- Regulatory Affairs - download module details here (PDF)
- Research project- download module details here (PDF)
The above modules make up the first 40 credits/Year 1 of the 60 credit Bachelor of Science (Honours) in Quality for Industry (Add-On Degree)
The remaining 20 credits are offered in Year 2, subject to their being a viable number of applications, at a fee of €2,000 (not Springboard funded).
On successful completion of this programme the learner will/should be able to:
1. Understand quality management systems and their implementation
2. The regulatory framework governing the medical device and pharmaceutical sectors
3. The application of statistics to quality assurance
4. Research methods and project management
5. The interpretation of regulations and the quality assurance systems that ensure these regulations are adhered to
6. Statistical process control tools that are used to identify and improve on quality issues
7. The role of the quality assurance department in maintaining and advancing quality within an organisation
8. Review, with the use of statistical tools, the performance of various manufacturing systems with a view to optimising manufacturing output
9. Design and implement quality tools that help optimise the overall quality management system
10. Write technical procedures that implement regulatory guidelines
11. Select the appropriate statistical tool to be used in the analysis of various manufacturing operations
12. Source scientific information and design and execute a research project
13. Make decisions in response to non-compliance issues
14. Make decisions on various quality issues and write technical documents explaining such decisions
15. Work on their own, or in a team, in the analysis of quality issues and the identification of new quality tools to improve quality
16. Plan and execute various projects associated with quality within an organisation
17. Train others in quality management tools and techniques
18. Identify the training needs of personnel in an organisation and deliver the quality aspects of staff training
19. Evince a commitment to lifelong learning
20. Apply their knowledge in one area to other related areas
21. Promote a work culture that is ethically based and focussed on continuous improvement
Learners can progress on to Year 2 of the Bachelor of Science (Honours) in Quality for Industry (Add-On Degree).
Course Start Date:
Delivery is mainly online.
You will also be required to attend the GMIT campus for additional sessions on Wednesday and Thursday evenings from 18:00 to 22:00. (September 2021 to May 2022)
Applications can be made online at https://apply.gmit.ie Please select application type L8
Places will be awarded on academic merit. If all places are not filled by those holding the entry requirement, Recognised Prior Learning may be offered to those not holding the entry requirement.
School: School of Science
Department: Department of Biopharmaceutical & Medical Science
Head of Department: Dr. Eugene McCarthy
Contact person for the course
Graduate Studies & Professional Development
Galway Mayo Institute of Technology