Quality Assurance Manager - MedTech, ISO 13485 Lead

Cure Talent Ltd; Stevenage; Hybrid; GBP 65,000 - 95,000; Full time

Job summary

Cure Talent Ltd. is partnered with a specialist medical device manufacturer to recruit a Quality Assurance Manager in Stevenage with two days per week from home.

You will take full ownership of the ISO 13485 QMS and lead quality activity across the business, aligning with leadership to sustain rapid growth. This role covers CAPA, non-conformities, audits (internal, supplier and Notified Body), batch release support, traceability and regulatory documentation, including MDR CE marking work.

Qualifications

• Experience in medical device quality management systems.
• Hands-on development and maintenance of QMS processes.
• Familiarity with MDR/ISO 13485 regulatory environments.

Responsibilities

• Own ISO 13485 QMS and lead quality activity across the business.
• Plan and perform internal, supplier and Notified Body audits.
• Manage CAPA, non-conformities, change control and document control.
• Support batch release, traceability, complaints and post-market activities.
• Contribute to CE marking maintenance under MDR and regulatory docs.

Skills

ISO 13485

QMS development

Internal audits

Supplier audits

CAPA management

Notified Body audits

Job description

Cure Talent Ltd. is partnered with a specialist medical device manufacturer to recruit a Quality Assurance Manager in Stevenage with two days per week from home.

You will take full ownership of the ISO 13485 QMS and lead quality activity across the business, aligning with leadership to sustain rapid growth. This role covers CAPA, non-conformities, audits (internal, supplier and Notified Body), batch release support, traceability and regulatory documentation, including MDR CE marking work.