Quality Assurance Consultant

Cure Talent is delighted to be working with a fast-growing specialist consultancy that delivers tailored Quality and Regulatory support to some of the UK’s most exciting MedTech innovators.

Due to their exceptional continued growth, we’re looking for a QARA Consultant with a strong focus on Quality Assurance to support clients across the Midlands region – from early-stage start-ups building their QMS from scratch to established companies navigating remediation, audit readiness, and compliance improvements.

This is a hands-on, client-facing role supporting multiple high-impact projects while collaborating with a forward-thinking team of quality & regulatory professionals.

You will:

• Lead QMS development, implementation, and ongoing maintenance in line with ISO 13485, 21 CFR Part 820, and MDSAP requirements.
• Provide guidance on quality system gaps and deliver remediation plans to ensure audit readiness.
• Support internal and external audits (Notified Bodies, MDSAP, FDA), including mock audits, CAPA management, and audit defence.
• Deliver operational quality support – from document control, SOP development and training, to batch review, DHRs, and NC investigations.
• Collaborate closely with RA, design, clinical, and operations teams to embed robust, compliant quality processes.
• Contribute to continuous improvement initiatives and client training programs.

The ideal candidate will have:

• Proven experience in Quality Assurance within the Medical Device industry, ideally with exposure to multiple QMS environments.
• Strong working knowledge of ISO 13485, MDR, 21 CFR 820, and ISO 14971.
• Audit experience (internal & external) and familiarity with CAPA, NCs, and change control processes.
• A consultancy mindset – able to quickly assess client needs, propose practical solutions, and manage multiple projects with minimal supervision.
• Excellent interpersonal and communication skills – this is a visible role requiring regular client interaction.

If you're looking for an exciting opportunity to be part of a rapidly expanding company at the forefront of health technology innovation, get in touch today!