Real Staffing Group
Our client is a fast growing manufacturer of PPE/RPE products. They are experiencing a period of rapid growth and our need of a Senior Quality Specialist in the team reporting to the Head of Quality.
The Senior Quality Specialist will be responsible for the following;
PPE testing and technical files.
Liaising with Notified bodies as required ensuring that Notified Body non-conformities are minimised.
The Senior Quality Specialist will complete activities to ensure compliance with ISO 13485 and maintenance/improvement of the company’s Quality Management System (QMS).
Supporting the Quality Manager with general administration.
Promote Quality, Quality Management Systems and Good Manufacturing Practice (GMP) awareness at all levels of the business
Work closely with other key departments within the business to support and advise on good working practices in line with the requirements of applicable PPE/medical device legislation.
The Senior Quality Specialist will promote the Company’s purpose and vision and ownership of its values and strategic objectives
The Senior Quality Specialist will ensure technical files are collated and updated when required.
Arrange required testing and review test reports.
Assist with the validation of sterilisation and packaging processes.
Carry out QC inspections and checking samples coming as required.
Investigate and report on non-conformances, customer complaints and CAPA issues within specified timeframe.
Responsible for Notified Body Audits/External Audits.
Complete internal audits as required.
The Senior Quality Specialist will assist with the creation and control of quality documents and quality records (Quality Manual, Procedures, forms etc).
Assist with the creation of procedures (SOPs) and work instructions for all departments.
Assist with the monitoring, measurement and recording of environmental conditions significant to preservation of product and for packaging of product to be sterilised. General:
To assist with the Company’s future strategy and direction of maintaining a first-class manufacturing capability and helping to build on its continuous process improvement programme.
Understand H&S Regulations.
Responsible for self-development and to participate in the company’s performance development process
Either Degree qualified or proven practical record in quality assurance
Ideally knowledge of PPE/RPE or at least medical device QA processes
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, United Kingdom | Partnership Number | OC387148 England and Wales