Job Title: Senior Quality Engineer
Key Responsibilities:
1. Develop and maintain the quality management system, ensuring seamless integration with all processes in accordance with ISO 13485, MDD 93/42/EEC & MDR 2017/745.
2. Act as a deputy for the management representative, providing leadership in their absence.
3. Promote collaboration across departments to guarantee products meet customer requirements.
4. Effectively manage product introductions and change controls in line with ISO 13485, MDD 93/42/EEC & MDR 2017/745 standards.
5. Review and release batch paperwork for product releases.
6. Contribute to new product introduction programs to ensure smooth implementation according to ISO 13485 standards. Generate Product Technical Files and associated studies when necessary.
7. Maintain the customer complaint investigation process, ensuring compliance with MDD 93/42/EEC & MDR 2017/745 vigilance requirements and assisting in product recalls and corrective/preventive actions.
8. Participate in routine failure investigations and process troubleshooting.
9. Maintain plant trending and continuous process improvement programs.
10. Participate in the Plant Corrective Action Program.
11. Contribute to the Internal Quality Audit Program.
12. Coordinate and maintain the Calibration Programme.
13. Coordinate and maintain the Validation Programme.
14. Maintain the Plant Environmental and Cleaning/Housekeeping Programme, including sub-contractor maintenance.
15. Maintain the Plant Laundry and Rodent Control Sub-Contractors to required standards.
16. Facilitate vendor assessments and maintenance.
17. Ensure quality system and product requirements are incorporated into plant training programs designated trainer.
18. Adhere to Plant Safety requirements and Health & Safety requirements relating to your work, assuming responsibility for those aspects of the OH&S System over which you have control to ensure the health and safety of yourself and others.
Qualifications:
* Minimum 2-3 years' experience as Quality/Validation Engineer in Medical Device/Pharmaceutical Environment.
* Third level qualification in Engineering / Manufacturing / Quality with emphasis on Medical Device / Biomedical. Minimum Bachelor's degree in a Science / Engineering / Quality related discipline.
* An Associate position may exist where there is limited experience and will be assigned to an experienced Engineer.