Senior Quality Engineer

Help take a next-generation class III medical device to the US. Our client is designing and manufacturing a Class III medical device, and their latest device is generating real excitement among leading surgeons, has strong clinical momentum behind it, and is now moving towards the US market. As they prepare for FDA, they're growing their quality systems team and adding a Senior Quality Engineer. The role You'll take ownership of significant parts of the ISO 13485 quality management system in a small, growing team, where you'll have a real say in how quality is done. Your focus areas will include:

• Supplier management
• Equipment validation
• Document control
• Validating the business and QMS software the company uses
• Supporting FDA readiness across the business What you'll bring
• Strong hands-on experience with ISO 13485, either across several quality engineering roles or by owning large parts of a QMS
• Proven experience in supplier management and equipment validation
• A background working in an electronic QMS
• An all-rounder mindset: you're happy to turn your hand to whatever the business needs What would set you apart
• Experience at an FDA-registered manufacturer
• Software or computer system validation Why this role
• An innovative implant with a clear route to the US market
• A visible role where your work directly shapes the company's FDA readiness
• The chance to see an FDA journey first-hand.