Description
QA/RA Executive - £30,,000 plus benefits -North LondonAn SME who have tripled in size in the last 2 years need a QA/RA executive to join their growing organisation.
This dynamic and entrepreneurial business is looking for a 'hands on', energetic team player who can hit the ground running.
Working for this company role will also expose you to top class training and encourage your development as a QA/RA professional.
Skills/Experience Required:
Management of ISO 13485 Quality Management System (including but not limited to)
- Development of new procedures as required
- Internal audits
- Second party supplier audits (overseas travel occasionally required)
- Post market surveillance
- Control of documents and changes
- Handling of complaints (customer and supplier)
- Management of approved suppliers file
- Packaging and artwork version control
- Traceability and batch numbers
- Design history of all new products
- Adverse event reporting
- Liaison withChinaoffice on 'joint procedure projects'
- Document control (standards , directives , regulations etc.)
- Quality Management Representation
Creation and management of Technical Files for Class I, IIA and IIB Medical Devices
(including but not limited to)
- Efficacy data
- Stability data
- Design history and design development
- Manufacturing instructions and procedures
- Risk Management
- Clinical evaluation
- ER checklist
Personal Characteristics:
- Strong communication skills
- Team player who can get involved
- Sociable
This role is looking to pay up to £35,000 and is an excellent position for someone looking to embrace an exciting new opportunity. If you are interested in this position, please contact Jonny Montgomery on for further details.
To find out more about Real please visit www.realstaffing.com