MedTech Quality Manager: ISO 13485 Lead, Remote 2 days/wk

Cure Talent; Stevenage; Hybrid; GBP 65,000 - 90,000; Full time

Job summary

Cure Talent are partnering with a specialist medical device manufacturer whose portable neonatal incubators are deployed in challenging environments across global markets. As Quality Manager, you will own the ISO 13485 QMS and lead quality across the business, based in Stevenage, Hertfordshire with two days per week working from home.

This role offers a defined growth path into regulatory affairs and potential PRRC responsibility as the business scales, with early involvement in MDR/Notified

Qualifications

• Proven quality management experience within the medical device industry.
• Strong ISO 13485 knowledge, including hands-on QMS development and maintenance.
• Experience planning and conducting internal and supplier audits, with exposure to Notified Body audits.
• CAPA management, non-conformance handling and document control experience.
• Working knowledge of the EU MDR; FDA QMSR experience is a plus.
• Interest in regulatory affairs and desire to grow into it.
• Practical, roll-your-sleeves-up mindset suited to a fast-moving SME.

Responsibilities

• Maintain, develop and improve the QMS in line with ISO 13485:2016 and medical device regs.
• Lead non-conformity management, CAPA, change control, document control and training.
• Plan and conduct internal, supplier and Notified Body audits.
• Manage supplier qualification, monitoring and performance reviews.
• Support batch release, traceability, complaint handling and post-market surveillance.
• Contribute to CE marking maintenance under MDR, CREs, PSURs and regulatory docs.
• Maintain awareness of regulatory changes and support broader regulatory strategy.

Skills

ISO 13485

QMS development

Internal audits

Supplier audits

CAPA management

Notified Body audits

Regulatory awareness

Regulatory affairs interest

Job description

Cure Talent are partnering with a specialist medical device manufacturer whose portable neonatal incubators are deployed in challenging environments across global markets. As Quality Manager, you will own the ISO 13485 QMS and lead quality across the business, based in Stevenage, Hertfordshire with two days per week working from home.

This role offers a defined growth path into regulatory affairs and potential PRRC responsibility as the business scales, with early involvement in MDR/Notified