Status:
Available from January 2023
Location:
South Wales
Exp. years:
20
Specialisms:
CAPA, Audits, ISO 13485, Risk, DHF, Tech File, MDR, Six Sigma
Availability:
Immediate
Overview:
A Medical Device Quality & Regulatory consultant has full-time availability after completing a project in December. They are available for 40 hours per week, are based in South Wales, and open to some travel.
- 20+ Years experienced QA/RA professional.
- Developed QMS to ISO13485, ISO9001, ISO14971 & 21CFR820. MDR Knowledge.
- Consultant, Engineer, Trainer and Manager
- Produced DHFs, Technical files and 510K.
- Six Sigma Black Belt & Auditor.
- CAPA, MDR, PMS, FSCA, N.C.R and Recall.
- M.Sc in Electronic Product Manufacturing.
- Lead multiple projects NPD, Lean, Risk, Supplier Development, PMS and Life Cycle.
- Experience in multiple manufacturing processes: Moulding, machine shop, testing, S.P.C, R&R studies, DoE, Validation, clean room
For more information on this person, you can reach me via nathan.puxty@capusearch.com / 07742773353