Head of Quality
• With experience of more than 50 Notified Body 13485/CE Audits, Richard can provide consultancy to ensure you are ready for these important audits. Often, clients require QMS Consultancy to act as Head of Quality during such audits.
• Any support in the future will depend on your own business requirements and staffing levels. This can range from a weekly on-site contracted Head of Quality role, to less frequent support such as review meetings and audits on a 2-monthly cycle.
• Mentoring and training of an existing staff member who is responsible for Quality within your organisation is often the favoured support method.
• It is worth noting that the MDR/IVDR's requires a Head of Quality to exist in all medical device companies and that it is permissible for this to be an outside contractor.
• Ongoing support activities may include
- Writing Technical File documents
- Management of CAPA for product improvement actions and customer complaints.
- Control activities for Suppliers or Subcontract Manufactures including Quality Agreements and Supplier Audits
- Internal Audits
- Running Management Review Meetings
- Development of specifications for materials and/or product
Contact us today to see how we might help you!.