Quality Manager (Medical Device)

MCS Group is delighted to be partnering with our successful client, who is an innovative medical device company. They are seeking an experienced Quality Manager to take ownership of the Quality Management System (QMS).
This role will be key to ensuring compliance across clinical, development, and commercial operations while driving a strong culture of quality, continuous improvement, and regulatory excellence.

As the Quality Manager, you will:

• Lead and maintain the Quality Management System (QMS) in line with ISO 13485, MDR, and FDA regulations, ensuring ongoing compliance and continuous improvement
• Oversee key quality processes, including CAPA, audits, risk management, complaints, and post-market surveillance
• Support clinical and regulatory activities, including submissions, vigilance reporting, and compliance with ISO 14155 and GCP
• Drive cross-functional quality initiatives, training, and performance monitoring to embed a strong culture of compliance and operational excellence

You will have:

• Experience in Quality Management within medical devices or life sciences
• Strong knowledge of ISO 13485, MDR, FDA 21 CFR Part 820, and related frameworks
• Experience with CAPA, audits, risk management, and post-market surveillance
• Knowledge of clinical and regulatory requirements (ISO 14155, GCP)
• A degree in Life Sciences, Engineering, or related field (additional certifications desirable)
• Experience with eQMS systems

You will get:

• Hybrid working
• Health care
• A key role within a growing and innovative organisation

To speak in absolute confidence about this opportunity please send an up to date CV via the link provided or contact Kathy Donaghey Technical and Engineering Manager at MCS Group 028 96935521
Even if this position is not right for you, we may have others that are. Please visit MCS Group to view a wide selection of our current jobs www.mcsgroup.jobs
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