Quality Engineer

We’re looking for a hands-on Quality / Manufacturing Engineer with strong experience in Class IIb/III medical devices to join a growing and dynamic team. This role is ideal for someone who thrives in regulated environments and enjoys working cross-functionally across production, quality, and suppliers.

Key Responsibilities

• Support manufacturing and quality processes for sterile medical devices
• Drive root cause investigations for manufacturing-related issues
• Manage and support CAPA, non-conformances, and complaints
• Work closely with production teams and external suppliers
• Lead and support change control processes
• Contribute to process validation and risk management activities
• Review and update SOPs and work instructions
• Participate in internal and external audits (front & back office)
• Experience with Class IIb/III devices
• Strong knowledge of ISO 13485 and 21 CFR 820
• Background working for a legal manufacturer or subcontract manufacturer
• Understanding of:
• QC & GD&T on drawings
• Process risk management & validation
• Experience liaising with suppliers and production teams
• Experience setting up new production lines/processes
• Exposure to additive manufacturing
• Lead auditor training
• Experience in a start-up environment
• Authorship of procedures

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