What you'll be doing: • Manage CAPA activities and associated reporting • Conduct and support internal and external audits • Manage QMS and relevant quality documentation • Advise engineering, production and design teams on relevant regulatory requirements and standards • Provide internal guidance and training relating to QMS documentation and processes • Develop new and improve existing QMS documentation and processes
What you will bring to the role: • Previous experience managing QMS systems in a medical device or pharmaceutical setting including CAPA, NCRs, ECNs, ECRs etc • Ideally detailed knowledge of ISO 13485, MDD and FDA regulations • Experience performing internal audits and hosting external audits • Excellent report writing and communication skills
Salary: £38,000 + Bonus + Hybrid working + Benefits
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