Senior Quality Specialist - PPE/RPE
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
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales