Quality Assurance Specialist – Med Devices & IVDs (Hybrid)

Medichecks; Bingham; Hybrid; GBP 30,000 - 35,000; Full time

Benefits offered by this job

25 days holiday + bank holidays

Hybrid working – UK-wide

Private healthcare options

Employee discount on Medichecks tests

Career development opportunities

Job summary

Medichecks is seeking a Quality Assurance Specialist to join our growing team in a hybrid role based near our Nottingham head office. You will support the Quality and Regulatory team, ensuring QMS compliance across the business, coordinating CAPA activities, and driving continuous quality improvements.

The ideal candidate has at least 2 years of experience in Medical Devices/IVD, knowledge of ISO 13485, IVDR and UK MDR, and experience with an eQMS system. Hybrid working from the UK is offered.

Qualifications

• Minimum 2 years in Medical Device & IVD industry.
• Experience with ISO 13485, IVDR, UK MDR.
• Experience maintaining and auditing QMS documents.

Responsibilities

• Maintain, improve, and audit readiness of ISO 13485 QMS.
• Manage CAPA and non-conformances from logging to resolution.
• Prepare monthly trend reports on CAPAs and non-conformances.
• Update SOPs to ensure QA processes are current and communicated.

Skills

Quality Assurance mindset

CAPA handling

Documentation & SOPs

Stakeholder communication

Auditing

Tools

eQMS (MasterControl/Q-Pulse)

Job description

Medichecks is seeking a Quality Assurance Specialist to join our growing team in a hybrid role based near our Nottingham head office. You will support the Quality and Regulatory team, ensuring QMS compliance across the business, coordinating CAPA activities, and driving continuous quality improvements.

The ideal candidate has at least 2 years of experience in Medical Devices/IVD, knowledge of ISO 13485, IVDR and UK MDR, and experience with an eQMS system. Hybrid working from the UK is offered.