Senior Quality Engineer in Leeds

This is a rare opportunity to join a high-growth medical device startup that has raised £60M from top-tier investors and is scaling rapidly towards global commercialisation. The company is building next-generation medical technologies that will meaningfully improve patient outcomes.

As Senior Quality Engineer, you will sit at the heart of product development and scale-up. You’ll help shape how quality is embedded into the organisation from early clinical and commercial stages through to full manufacturing scale. If you enjoy ownership, influence, and building robust systems in fast-moving environments, this role will give you real impact.

The Role

Reporting into the CTO, you will act as the quality lead for new products, processes, and technologies, partnering closely with R&D, Engineering, Manufacturing, and Operations. You’ll ensure that every product released meets the highest standards of safety, performance, and regulatory compliance, while also helping build a pragmatic, scalable Quality Management System suitable for a rapidly growing MedTech business. This is a hands-on, visible role where your decisions will directly shape how the company grows.

What You’ll Be Doing

• Act as the primary quality partner for new product introductions, new equipment, and process changes.
• Lead risk management, quality planning, and validation strategy across the product lifecycle.
• Review and approve process validation activities (IQ, OQ, PQ), protocols, and reports.
• Develop and maintain quality plans, control plans, sampling strategies, and test methods.
• Apply statistical and quality tools (SPC, capability analysis, acceptance sampling) to drive data-led decisions.
• Support design transfer from R&D into manufacturing and scale-up environments.
• Lead or support engineering studies to characterise and optimise product and process performance.
• Review and approve FAT/SAT documentation for new manufacturing equipment.
• Drive non-conformance investigations, deviations, and CAPAs, ensuring root cause and long-term fixes.
• Support and manage Engineering Change Orders (ECOs) and assess regulatory impact.
• Maintain and evolve QMS documentation and processes, ensuring scalability and audit readiness.
• Support regulatory submissions linked to product and process changes.
• Actively support regulatory inspections and customer audits, helping the company stay inspection-ready at all times.
• Champion a culture of quality, accountability, and continuous improvement across the business.

What We’re Looking For

Experience & Background

• Degree in Engineering, Science, or a related discipline (or equivalent industry experience).
• Typically 5+ years’ experience in Quality Engineering, Manufacturing, or Process Engineering within medical devices or regulated life sciences.
• Strong hands-on experience with process validation, risk management, and quality planning.
• Proven experience working within ISO 13485 environments (FDA QSR and MDR exposure highly beneficial).
• Experience supporting new product introductions and manufacturing scale-up.

Technical & Regulatory Skills

• Solid understanding of medical device QMS, GMP, and regulatory expectations.
• Confident using statistical quality tools and interpreting manufacturing data.
• Experience working with electronic QMS systems.
• Understanding of software validation principles is a plus.

Mindset & Attributes

• Comfortable operating in startup environments where priorities evolve and ownership matters.
• Confident influencer — able to balance quality rigour with commercial pace.
• Highly organised, proactive, and comfortable managing multiple workstreams.
• Strong communicator who works well across engineering, R&D, and operations teams.
• Motivated by building things properly, not just maintaining the status quo.

Why Join

• £60M backed – strong financial runway and ambitious growth plans.
• Real influence – help design and scale quality systems, not just operate them.
• High-growth environment – exposure to clinical, regulatory, and commercial scale-up.
• Meaningful impact – your work directly supports patient safety and product success.
• Career acceleration – grow with the company as it moves towards global scale.

If this sounds like you, you’ll fit right in.