Process & Validation Engineer

A privately owned UK manufacturer making single-use medical devices and components for customers worldwide. They're growing, and want someone to tighten up how moulded parts get validated and moved into production.

Company mission

Precision manufacturing of single-use medical devices that end up in clinical use around the world.

Role Overview

Reporting to the Product Quality Manager, you'll set the standard for process validation and statistical methods across cleanroom injection moulding and assembly. You'll run moulding validations, support new product and process introductions, and make sure every project lands in production fully documented. You'll work day to day with tooling, technical, quality and production teams.

£32,000 to £36,000 depending on experience. Full-time, on-site.

What You'll Own - Validation

• Planning and running injection moulding validation protocols, including the risk management that sits around them
• Writing and maintaining validation documentation, and producing complete handover packs into production
• Contributing to the Validation Master Plan and upgrading validation procedures and systems
• Overseeing metrology for new and existing projects

What You'll Own - Process and Quality

• Applying statistical methods to manufacturing and quality data
• Tracking and reporting monthly scrap, and driving it down
• Technical and validation support to the Quality team, plus backup cover on final product release
• Working directly with customers and suppliers, including occasional site visits

What We're Looking For - Essential

• Experience in validation, QC, metrology or process engineering within regulated manufacturing, or formal validation training backed by hands-on experience
• A solid grasp of validation principles, methodology and documentation
• Statistical analysis experience
• Able to read and interpret CAD data
• Strong Excel and Microsoft Office skills
• Confident dealing with customers and suppliers, including by phone
• Full UK driving licence and able to travel to customer sites

What We're Looking For - Useful

• Minitab
• Injection moulding and polymer processing knowledge

Package

Health cash plan, company pension, on-site parking and bank holidays off on top of annual leave.

Get in touch for a confidential conversation. Imogen@waverecruitment.co.uk