CT19

www.ct-19.co.uk

1 Job

10 Employees

About the Company

We aim to positively impact people's lives by connecting talent with opportunity through a well-managed, ethical recruitment process.

Initially working within biotechnology and medical technology, we are now partnering with 'Tech For Good' companies across The UK, EU & US.

Listed Jobs

Company Name: CT19
Job Title: Product Quality Engineer - Medical Devices
Job Description: **Job title** Product Quality Engineer – Medical Devices **Role Summary** Oversee quality assurance and control throughout product development, manufacturing, and post‑market activities for medical devices. Develop and maintain Design History Files, manage non‑conformances and CAPAs, support verification/validation, and provide regulatory guidance to ensure compliance with ISO 13485, FDA 21 CFR 820, and CE/510(k) requirements. **Expactations** - Lead and support quality engineering activities across medical, veterinary, and non‑destructive testing product lines - Contribute to design and manufacturing documentation to enable effective manufacturing and testing - Oversee risk management planning, assessment, and reporting for new and modified products - Support design transfer, supplier qualification, and quality test method validation - Generate and maintain quality documentation (SOPs, work instructions, inspection procedures) - Manage NCRs, CAPAs, and continuous improvement initiatives - Collaborate with R&D, suppliers, and manufacturing teams to embed quality throughout the lifecycle - Provide training and guidance on regulatory compliance and quality standards **Required Skills** - Strong knowledge of product development, manufacturing, and quality systems in regulated industries, ideally medical devices - Familiarity with ISO 13485, FDA QSR, FMEA, risk management, medical device cybersecurity - Proficiency with Lean/Six Sigma methods and tools such as Minitab, DOE, SPC - Excellent planning, problem‑solving, and communication skills; capable of independent and collaborative work **Required Education & Certifications** - Degree in Science or Engineering, or equivalent experience - Recognised Quality Management System qualification (e.g., ISO auditor) or equivalent experience ---

Kidlington, United kingdom

On site

25-02-2026