Quality Assurance Specialist - Senior Role
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Our company is seeking a Quality Assurance Specialist to join our team in a senior role. This position involves ensuring that our products meet customer requirements and adhering to quality management systems.
Key Responsibilities:
* Integration & Maintenance of the Quality Management System with all processes in accordance with ISO 13485 standards.
* Deputising for the Management Representative in their absence.
* Providing support to departments to ensure that products manufactured meet customer requirements.
* Ensuring that product introductions & change controls are effectively managed in accordance with ISO 13485 standards.
* Review and Release of batch paperwork for Product release.
* Participation in new product introductions programmes to ensure effective introduction in accordance with ISO 13485 standards.
* Maintenance of Customer Complaint investigation process, vigilance requirements, assisting in product recalls & corrective/preventive action programme.
* Participation in routine Failure Investigation & process trouble-shooting.
* Maintenance of plant Trending & Continuous process improvement programmes.
* Participation in Plant Corrective Action Programme.
* Participation in Internal Quality Audit Programme.
* Co-ordination & maintenance of Calibration Programme.
* Co-ordination & maintenance of Validation Programme.
* Maintenance of Plant Environmental & Cleaning/Housekeeping Programme, including sub-contractor maintenance.
* Maintenance of Plant Laundry & Rodent Control Sub-Contractors to required standards.
* Vendor Assessment liaison & Maintenance.
* Ensuring that quality system & product requirements are included in the plant Training Programmes designated trainer.
* 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.
Requirements:
* Strong understanding of quality management systems.
* Ability to integrate and maintain quality management systems with all processes.
* Excellent communication skills.
* Strong problem-solving skills.
Benefits:
Our company offers a competitive salary and benefits package.
How to Apply:
If you are interested in this role, please submit your application through our website.