Quality Assurance Officer - Medical Devices

Quality Assurance Officer | Medical Devices

£40,000 – £45,000 | West London | Hybrid – 2 days per week in the office

We are currently working on an exciting opportunity for a Quality Assurance Officer to join a growing international healthcare business with a diverse product portfolio spanning medical devices, consumer healthcare and cosmetics products.

This is a great opportunity for a QA professional who wants genuine exposure across QMS, medical devices, complaints, CAPA, supplier quality, technical documentation and regulatory compliance.

The business operates across multiple European markets, so this is a role where you’ll need to be technically strong, highly organised and comfortable keeping up with changing regulations.

What will you be doing?

You’ll play a key role in supporting the day-to-day operation and continuous improvement of the Quality Management System, including:

• Supporting the maintenance and improvement of the ISO 13485 QMS
• Updating SOPs, work instructions and quality documentation
• Supporting internal audits and preparation for external Notified Body and regulatory audits
• Reviewing batch records, Certificates of Analysis and imported product documentation prior to release
• Managing and investigating non-conformances and CAPAs
• Supporting customer and trade complaint investigations, including root-cause analysis and complaint trending
• Supporting supplier quality activities, quarantine processes, returns and product traceability
• Reviewing labelling, packaging copy and artwork against regulatory and technical requirements
• Maintaining technical documentation for medical devices and consumer products
• Monitoring regulatory developments including PPWR, CLP, REACH and GPSR
• Working closely with Supply Chain, Marketing, Regulatory, Technical and external partners

What are we looking for?

Ideally, you’ll have a minimum of 2 years’ hands‑on QA experience within a regulated environment, with experience in:

• Medical Devices / ISO 13485 environment - ideal
• A good understanding of UK/EU Medical Device Regulations (MDR)
• QMS processes and documentation
• CAPA and non-conformance management
• Complaint handling and investigation
• Batch release / quality documentation

Experience within healthcare, cosmetics or other regulated consumer products would also be advantageous.

You’ll also need to be someone who is:

• Highly detail-oriented – comfortable working with technical documentation and quality records.
• A quick learner – able to understand and apply new regulations as they develop.
• Analytical – capable of investigating issues, identifying root causes and following actions through.
• A strong communicator – comfortable working across Quality, Supply Chain, Marketing, Regulatory and external stakeholders.
• Hands‑on and adaptable – this is a broad QA role in a lean and agile environment, so you’ll need to be comfortable getting involved in both technical quality activities and the more administrative/detail‑heavy aspects of the role.

Why consider it?

This is an excellent opportunity for someone looking to broaden their experience across medical devices, consumer healthcare and wider regulated products, while working within an international organisation.

You’ll gain exposure to a broad range of quality activities rather than being restricted to one narrow area of QA.

West London – 2 days per week in the office

Keywords: Quality Assurance Officer, Quality Officer, QA Officer, QA/RA Officer, QA/RA, Medical Devices, Medical Device, MDR, MDD

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