Lead QA Consultant- FDA Site Readiness- South West- 6 months contract £50-55ph Medical Devices
A Medical Device company in the South West are looking for a QA Consultant to lead on the FDA audit site readiness project, the purpose of the role is to manage FDA site readiness. This is a PMA inspection which is limited to one product line so there is a very defined set of deliverables.
You need to have good leadership skills but who is also able to be hands on and is not afraid to get their hands dirty. The business does not need somebody who just manages and delegates. This person needs to have energy and drive to work with the organisation to get the readiness actions completed.
- Experienced in preparing a site for Audit readiness
- Experienced in FDA regulatory requirements for med devices
- Preferably has experience as a Quality Management or lead role and has audit facing experience
- Good project management (PM) skills (Certification not required)
- Good working knowledge of risk mitigation and resolving project conflicts
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