Courses in

Science

Certificate in Quality for the Medical Device Industry

Open for applications on www.gmit.ie

Discipline: Science

Programme Code: 

GA_SQMDG_N08

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

Credits: 40

Places: 25

Fee: 

2,500 Euros (subject to confirmation) for the 40 credit Minor Award

Why Study?

  • 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 www.gmit.ie. 

 

Programme Modules

  • 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).

Learning Outcomes: 

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

 

 

 

 

 

 

 

Follow-on Studies: 

Essential Information: 

Course Start Date:

September 2021

 

Delivery

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)

 

Application Process:

Applications can be made online at https://apply.gmit.ie  Please select application type L8

 

Contact Us

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
Dublin Road
Galway

Email: learn@gmit.ie