Quality Manager

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

You will be joining a leading science-backed health and beauty brand as Quality Manager.

The Role

This is a brilliant opportunity for an experienced Quality professional to step into a pivotal, hands-on role reporting directly to the Operations Director. You'll be instrumental in developing, implementing, and maintaining a robust Quality Management System (QMS) for cutting-edge medical and Annex XVI devices.

• Maintain and continually improve the QMS in accordance with ISO 13485:2016, FDA QSR, MDSAP, and EU MDR.
• Ensure product compliance with EU MDR General Safety and Performance Requirements (GSPRs) and mandatory Common Specifications (CS).
• Manage the company's proactive Post-Market Surveillance (PMS) system in line with EU MDR, including developing PMS plans and compiling PSURs.
• Plan, conduct, and manage internal audits across all departments and levels.
• Implement and manage risk management activities in accordance with ISO 14971.
• Establish and maintain the supplier qualification, evaluation, and monitoring programme, including conducting supplier audits.
• Train employees on quality standards, regulatory requirements, and company procedures.

How You'll Dazzle Us

We're looking for someone who brings 5-7 years of progressive experience in a Quality Assurance role within the medical device sector. You will have demonstrable experience managing a QMS compliant with ISO 13485:2016 and FDA 21 CFR Part 820. Your technical knowledge must be expert level, with an in-depth understanding of the EU Medical Device Regulation (MDR 2017/745), including Technical Documentation, PMS, and Clinical Evaluation. Crucially, you'll be a proactive leader, proficient with QMS software and comfortable adapting to and implementing new digital tools to streamline processes. Experience with Annex XVI devices or MDSAP audits would be a real advantage.

What's Next

Ready to take on this exciting challenge? Apply via the form below.