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Opportunity for an experienced Quality Systems Engineer to join an established technology development and manufacturing business. As Quality Systems Engineer your activities will contribute to the overall business performance, compliance and quality of products. The business offers hybrid working, competitive salary, bonus and extensive benefits

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