Hands-on Quality Manager – Medical Devices, ISO 13485 & MDR

Artisan People; City Of London; On-site; GBP 60,000 - 75,000; Full time

Job summary

A leading science-backed health and beauty brand is seeking a Quality Manager. You will develop and maintain a robust Quality Management System for medical devices. The ideal candidate has 5-7 years of experience in quality assurance within the medical device sector, expert knowledge of EU MDR and ISO 13485:2016, and strong leadership skills. This role offers the chance to work in a pivotal position reporting directly to the Operations Director.

Qualifications

• 5-7 years of experience in a Quality Assurance role within the medical device sector.
• Experience managing a QMS compliant with ISO 13485:2016 and FDA 21 CFR Part 820.
• Expert level technical knowledge of EU Medical Device Regulation.

Responsibilities

• Develop and maintain a Quality Management System.
• Ensure compliance with EU MDR General Safety and Performance Requirements.
• Manage Post-Market Surveillance including developing plans.

Skills

Experience with ISO 13485:2016

Understanding of EU MDR

Proficiency with QMS software

Leadership skills

Job description

A leading science-backed health and beauty brand is seeking a Quality Manager. You will develop and maintain a robust Quality Management System for medical devices. The ideal candidate has 5-7 years of experience in quality assurance within the medical device sector, expert knowledge of EU MDR and ISO 13485:2016, and strong leadership skills. This role offers the chance to work in a pivotal position reporting directly to the Operations Director.