Quality Manager, Medical Devices: ISO 13485 QMS (Hybrid)

Guided Solutions; England; Hybrid; GBP 45,000 - 65,000; Full time

Job summary

A medical devices firm in the UK is seeking a Quality Manager to develop their Quality Management System in accordance with ISO 13485. This role involves both remote and office-based responsibilities, with key tasks including managing internal audits and ensuring compliance with regulatory standards. Candidates should have proven experience in the Medical Devices Industry and a strong understanding of quality management processes.

Qualifications

• Experience in the Medical Devices Industry is essential.
• Previous experience as a Quality Manager is required.
• Self-motivated individuals with a positive attitude are preferred.

Responsibilities

• Create a Quality Management System according to ISO 13485/9001.
• Manage daily operations of the Quality Management System.
• Liaise with overseas manufacturers/contractors for compliance.
• Carry out audits and ensure documentation accuracy.

Skills

Knowledge of ISO13485 & 9001

Knowledge of MDR and UKCA certification

Excellent communication skills

Problem-solving skills

Job description

A medical devices firm in the UK is seeking a Quality Manager to develop their Quality Management System in accordance with ISO 13485. This role involves both remote and office-based responsibilities, with key tasks including managing internal audits and ensuring compliance with regulatory standards. Candidates should have proven experience in the Medical Devices Industry and a strong understanding of quality management processes.