QA/RA Manager
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QA/RA Manager
My client, a Medical Device company based in Scotland are looking for a QA/RA Manager to join their company on a flexible basis. They are open to a full time or part time permanent employee so it might be a good role for someone who needs flexible hours.
The role:
* To maintain and improve the current Quality Management System maintaining CE mark for devices and ISO 13485 accreditation
* To provide guidance and leadership for all matters related to quality and regulatory affairs.
* To support application for device / product licences within EU, US, Canada and other territories.
Expected Qualifications
* At least degree level in appropriate area (Life Sciences, Biology, Quality management). Ideally with additional professional qualifications
Essential Experience:
* At least 5 years of experience within GxP setting
* Experience of managing and maintaining quality management systems preferably to ISO 13485
* Auditing experience preferably to ISO13485 standard
* Experience of medical device licence applications and maintenance
Desirable
* Experience of FDA 21CFR820 and 600 series
* Experience of dental devices
* Lead Auditor qualification
* Experience of PMA and CMDCAS
If you are interested then please get in touch by sending your cv or contacting Bethany on 02077587311