QMS Owner & Quality Lead — Diagnostics

Vero HR Ltd; Milton Ernest; On-site; GBP 45,000 - 65,000; Full time

Benefits offered by this job

Company pension

Free on-site parking

Job summary

Vero HR Ltd is seeking a proactive Quality Lead for a growing manufacturing business specializing in lateral flow diagnostic products. You will own the QMS, ensuring procedures are followed and the team maintains audit readiness.

The role involves managing documentation, SOPs, and cross-functional collaboration to embed quality across Technical, Manufacturing and Operations. The ideal candidate has experience in regulated quality environments, knowledge of ISO 13485, and a hands-on,

Qualifications

• Experience in a regulated quality environment, ideally in diagnostic/medical devices.
• Knowledge of ISO 13485:2016; experience with ISO 9001 considered.
• Experience maintaining a QMS and quality documentation.
• Proactive, hands-on approach to quality and compliance.

Responsibilities

• Take ownership of and manage the Quality Management System (QMS).
• Ensure SOPs and quality procedures are followed across the business.
• Maintain accurate quality documentation and records, ensuring they are reviewed and approved.
• Support for internal and external audits and readiness for audits.
• Identify opportunities to improve quality systems and processes in collaboration with teams.
• Work with Technical, Manufacturing and Operations to embed quality standards across the business.

Skills

ISO 13485 knowledge

QMS management

Documentation skills

Audit readiness

Independent working

Job description

Vero HR Ltd is seeking a proactive Quality Lead for a growing manufacturing business specializing in lateral flow diagnostic products. You will own the QMS, ensuring procedures are followed and the team maintains audit readiness.

The role involves managing documentation, SOPs, and cross-functional collaboration to embed quality across Technical, Manufacturing and Operations. The ideal candidate has experience in regulated quality environments, knowledge of ISO 13485, and a hands-on,