Quality Management System Lead
Gargrave, Yorkshire OR Dunstable, Bedfordshire
12 Month contract role
Our client is a global supplier of medical devices with a wide-reaching global footprint. They are currently recruiting for a QMS Lead.
This role will develop and implement a QMS to the Gargrave site certified to ISO13485:2016 and initially facilitate the transfer of manufacturing operations from the Dunstable to Gargrave site.
What you’ll do:
Fully develop the QMS for Gargrave site - adopting the existing QMS best-practice benchmarks form the existing manufacturing sites. Facilitating the transfer of manufacturing operations you’ll be leading the quality team on all aspects of the knowledge transfer – including supplier approval records, specifications, materials stability data, manufacturing process control and associated risk management.
The developed QMS will need to ISO13485:2016 certified and maintain compliance to applicable market regulatory requirements.
You’ll have several years experience within a similar role with methodical attention to documentation detail. Certified in Lead Auditor training with knowledge and experience in most if not all of the following:
MDSAP, FDA 21 CFR Part 803, FDA 21 CFR 11 and FDA 21 CFR Part 820. ISO 13485, ISO 9001, ISO 17025, Australian Regulatory Guidance, JPAL (MO-169), and CMDR.
On this occasion, LiCa Scientific is acting as an employment agency.