Royston Quality Assurance & Control Job Listings

Workable

Quality Technician

We're growing our team and looking for a Quality Technician who wants to work at the heart of a purpose led biotech company. Are you detail driven, quality obsessed, and ready to make a real world impact in healthcare? At LEX Diagnostics, we're shaking up the world of diagnostics. Our breakthrough technology delivers PCR test results in under 10 minutes, right at the point of care. It's science that moves fast, so that doctors and patients don't have to wait. As a Quality Technician, you’ll be making sure our consumable medical products meet the gold standard, from the moment components arrive to the second our products are boxed and ready to ship. You'll work closely with production, engineering, and quality teams, helping to maintain product integrity, patient safety, and full compliance with ISO 13485 standards. What you’ll be doing: · Carrying out inspections on incoming materials and finished products. · Supporting timely product releases with accurate documentation · Conducting in-process and final checks on our consumables · Preparing approved products for dispatch, safely and compliantly · Identifying and escalating quality concerns early · Keeping quality records up to date and inspection ready · Contributing to improvements in processes, tools, and documentation Requirements What we’re looking for: · Experience working in a regulated environment (ISO 13485 or cGMP is a plus) · A proactive mindset, you're not afraid to speak up when something looks off. · Experience in cleanroom environments and quality inspections · Comfortable adapting to new instructions and processes · Familiarity with stock control and quality documentation · Confidence using QMS tools and systems. What’s it like working here? We’re a small tight knit team of 45 with big ambitions. Everyone at LEX is driven by the same goal, to bring fast, accurate diagnostics to the point of care and improve outcomes for patients. We combine cutting edge science with everyday practicality, and we love people who think outside the box while staying grounded in quality and compliance. Who are we and what does the future hold for you? LEX Diagnostics was founded in 2020. Our innovative system integrates effortlessly into primary care settings, bringing PCR-level sensitivity to urgent care centres, physicians, labs, and pharmacies, all at a significantly lower cost per test than other molecular platforms. Bringing new diagnostics technology to market is tough! 2025 is a milestone year for us as we’ve just submitted dual 510(k) CLIA waiver applications to the U.S. FDA. This means you will be an important part of a high impact launch that will enhance your future career credentials. The Future In December 2023, QuidelOrtho invested in LEX Diagnostics, which included the exclusive option to acquire the company up to or shortly after 510(k) clearance by the FDA. In QuidelOrtho, we have an investment partner that recognises the capabilities of our team, and are excited for what we can continue to build together... We are optimistic to receive 510(k) clearance in late 2025 or early 2026. What this means for you · More Resources - Manufacturing scale, regulatory & distribution infrastructure · R&D Focus - Concentrated innovation around LEX platform and test menu · Career Mobility - As well as creating a cross-disciplinary development environment in science and engineering, LEX employees can transition into broader roles (e.g., regulatory affairs, global supply chain, sales, clinical affairs) across the integrated organisation. · Global Exposure - International workflows & markets (US & EU) · Impact & Stability - Increased product reach and organisational strength · Development - Structured programs and training opportunities 2026 should see the elevation of the LEX Diagnostics team from startup environment into a well-supported, international diagnostics powerhouse without sacrificing the very thing that made our team successful, innovation. You’ll help drive forward a unique, market-leading platform within a growing team that needs to invest in your development and career growth. Benefits Our working culture encourages entrepreneurship, shared ideas, and technical collaboration, while providing you the freedom to do your best work. We also offer fantastic employee benefits including: · Employer pension contribution of 10% (+3% personal contribution) · Private Medical Insurance · Life insurance · 25 days’ annual holiday plus bank holidays · Discounts and memberships to local sports facilities and the theatre This is your opportunity to join the team that's delivering the future of point of care diagnostics. Apply now and become a part of something genuinely meaningful.

Melbourn, Royston SG8, UK

Negotiable Salary