Job Title: Senior Quality Engineer
Role Summary:
* The Senior Quality Engineer is accountable for the integration and maintenance of the Quality Management System with all processes in accordance with ISO 13485, MDD 93/42/EEC & MDR 2017/745.
* This includes deputising for the Management Representative in their absence, providing support to all departments to ensure products manufactured meet customer requirements, and ensuring product introductions & change controls are effectively managed.
Responsibilities:
1. Integration & Maintenance of the Quality Management System:
o Ensure the integration and maintenance of the Quality Management System with all processes in accordance with the requirements of ISO 13485, MDD 93/42/EEC & MDR 2017/745.
2. Deputising for the Management Representative:
o Act as a deputy for the Management Representative in their absence.
3. Support to Departments:
o Provide support to all departments to ensure that products manufactured meet customer requirements.
4. Product Introductions & Change Controls:
o Ensure that product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485, MDD 93/42/EEC & MDR 2017/745.
5. Batch Paperwork Review & Release:
o Review and release batch paperwork for Product release.
6. New Product Introductions Programmes:
o Participate in new product introductions programmes to ensure that they are effectively introduced in accordance with the requirements of ISO 13485.
7. Product Technical Files Generation:
o Generate Product Technical Files & associated studies in accordance with MDD 93/42/EEC & MDR 2017/745 when appropriate.
8. Customer Complaint Investigation Process:
o Maintain the Customer Complaint investigation process, MDD 93/42/EEC & MDR 2017/745 vigilance requirements assisting in product recalls & corrective/preventive action programme.
9. Failure Investigation & Process Trouble-Shooting:
o Participate in routine Failure Investigation & process trouble-shooting.
10. Plant Trending & Continuous Improvement Programmes:
o Maintain plant trending & continuous process improvement programmes.
11. Corrective Action Programme:
o Participate in the Plant Corrective Action Programme.
12. Internal Quality Audit Programme:
o Participate in the Internal Quality Audit Programme.
13. Calibration Programme:
o Co-ordinate & maintain the Calibration Programme.
14. Validation Programme:
o Co-ordinate & maintain the Validation Programme.
15. Environmental & Cleaning/Housekeeping Programme:
o Maintain the Plant Environmental & Cleaning/Housekeeping Programme, including sub-contractor maintenance.
16. Laundry & Rodent Control Sub-Contractors:
o Maintain the Plant Laundry & Rodent Control Sub-Contractors to required standards.
17. Vendor Assessment Liaison:
o Liaise with Vendor Assessments.
18. Quality System & Product Requirements Training:
o Include quality system & product requirements in the plant training programmes designated trainer.
19. Health & Safety Requirements:
o 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.
Required Skills & Qualifications:
Qualified engineers with experience in quality management systems will be considered. The ideal candidate will possess excellent communication skills, be able to work independently, and have a strong understanding of quality management principles.
Benefits:
Competitive salary and benefits package offered.
Others:
Interested candidates please submit their applications via our website.
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