RAQA / QA Engineer at Doccla

London, England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

21 May, 26

Salary

0.0

Posted On

20 Feb, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Risk Management, Technical Documentation, ISO 14971, Jira Configuration, MDR Compliance, IEC 62304, Requirements Traceability, Verification & Validation, Technical File Integrity, Software Lifecycle Documentation, Notified Body Audits, SaMD, Clinical Evaluation, PMS/PMCF, Systems Thinking

Industry

Hospitals and Health Care

Description

🌍 A Bit About Us We’re Doccla, and we’re redefining where and how healthcare is delivered. Our Virtual Ward and Remote Monitoring Solutions enable hospitals and health systems to care for patients at home. We support patients across the full care journey from early discharge and acute recovery to long-term condition management and proactive care. We provide everything clinicians need to deliver safe, effective Virtual Care: medical-grade devices, logistics, patient onboarding, EHR integration, and an end-to-end clinical platform built around real-world workflows. We currently work with over 60% of NHS ICBs and supporting health systems across the including UK, Ireland, France, and the DACH region to reduce hospital pressure, improve outcomes, and create a more resilient model of care. We’re backed by top European investors, having secured £35m in Series B funding led by Lakestar, with participation from Elaia, General Catalyst, Speedinvest, and Bertelsmann. 🚀 Why Join Us? This is your chance to join Doccla at a key stage in our growth. We’re building the category leader in Virtual Care and Remote Patient Monitoring. You’ll be part of a highly entrepreneurial, mission-driven team that combines expertise across clinical, technical, commercial, and operational domains. We’re solving real problems for patients and health systems and growing fast. 🧑‍⚕️ What You’ll Do as a RAQA / QA Engineer The RAQA / QA Engineer will own and operationalise Risk Management and Technical Documentation (TD) execution across the Doccla SaMD platform. This role is central to ensuring MDR-compliant risk management, release-level technical file integrity, and structured traceability between requirements, verification & validation (V&V), risk controls, and labelling. The position is execution-focused, sitting at the interface between RAQA and Engineering, with clear responsibility for maintaining a defensible, audit-ready risk framework embedded into the product lifecycle. ✅ What Experience You’ll Bring to the Team 1. Risk Management Ownership (~60%) ● Own and maintain ISO 14971-compliant risk management files across all active product versions. ● Lead risk updates for each release (including patches). ● Ensure bidirectional traceability between: ○ Hazards ○ Hazardous situations ○ Harms ○ Risk controls ○ Requirements ○ Verification evidence ● Support Jira configuration and structured risk traceability outputs. ● Ensure alignment between risk documentation and: ○ Clinical evaluation inputs ○ PMS / PMCF signals ○ Field safety feedback ● Support closure of Notified Body non-conformities relating to risk management. ● Contribute to risk review during design changes and new feature introduction. 2. Technical Documentation & Release Review (~30%) ● Review Technical Documentation updates per release cycle. ● Ensure: ○ Requirements completeness and clarity ○ Traceability matrix accuracy ○ V&V evidence linkage ○ Consistency across IFU, risk file, and intended purpose ● Support structured TD remediation activities (Round 2 and ongoing maintenance). ● Participate in internal design reviews from a compliance perspective. ● Support preparation for Notified Body audits and surveillance activities. 3. Cross-Functional QA Engineering Support (~10%) ● Work closely with Engineering to ensure risk controls are implemented as specified. ● Support validation planning from a compliance standpoint. ● Provide structured input into software lifecycle documentation (IEC 62304 alignment). ● Contribute to continuous improvement of traceability systems and documentation tooling. 💡 What We’re Looking For ● 3–6 years’ experience in Medical Device / SaMD QA or RAQA Engineering. ● Strong working knowledge of: ○ ISO 14971 (Risk Management) ○ IEC 62304 (Software lifecycle) ○ EU MDR Technical Documentation requirements ● Experience working within release-based software environments. ● Demonstrated ability to manage traceability across requirements, risk, and V&V. ● Experience interacting with Notified Bodies is desirable. ● Strong systems-thinking mindset and ability to work with Engineering teams. 🧠 How We Work We empower everyone at Doccla to take ownership of their work and the company's mission. We act ethically and always put patient safety and outcomes first. To thrive here, you’ll need a can-do attitude and an action-oriented approach, along with a willingness to learn and grow through open feedback. We’re a hybrid team, with offices in London, Denmark, Germany, and Stockholm. Most of our team is London-based and enjoys in-person time at our WeWork HQ 1–3 days per week, where you’ll find great lunch, barista coffee, and a pet-friendly space. Some roles are fully remote, depending on the team and responsibilities. 🎁 What You’ll Get Annual Leave & Holidays 🌴 25 days annual leave + up to 8 UK bank holidays 🔄 Option to buy or sell holidays Remote Working 🏡 Flexible remote options 💻 £200 remote working stipend Financial Benefits 📈 Employee stock options 💸 4% pension on full basic pay 🛡️ 4x salary life insurance Health & Wellness 🩺 Private health insurance 🫄 4 months full pay for birthing parent* 👶🏽 4 weeks full pay for non-birthing parent* 🤒 Sick pay In-Office Perks (London HQ) 🍝 Free daily lunch 🐶 Pet-friendly office Other Benefits 📚 £500 L&D budget per person 🚲 Cycle to work scheme Via Smart Health: 🧑‍⚕️ 24/7 GP appointments 🧠 Mental health support 🥗 Nutrition & fitness advice 🧪 Second opinions & health checks 🏆 In Return for Your Hard Work A competitive compensation package (base + stock options), with half-year and annual performance reviews The chance to work on patient-first, system-level healthcare challenges in one of Europe’s leading healthtech companies Opportunities for growth and leadership we want you to challenge the status quo, own your impact, and continue developing, with our full support 🤝 Diversity at Doccla We embrace diversity. To build a great product, we need a team with a wide range of perspectives, backgrounds, and experiences. We’re committed to equal opportunity hiring regardless of race, religion, gender identity, sexual orientation, age, disability, or background. If you're excited about the role, we encourage you to apply even if your experience doesn't match every point. 🔐 Safer Recruitment We are committed to safer recruitment practices. As Doccla is a CQC registered company, a Disclosure and Barring Service (DBS) check will be required for all roles. It is an offence to apply for such work if you are barred from working with children or vulnerable adults.

Responsibilities

The RAQA / QA Engineer will be responsible for owning and operationalizing Risk Management and Technical Documentation execution for the Doccla SaMD platform to ensure MDR compliance. This execution-focused role interfaces between RAQA and Engineering to maintain an auditable risk framework throughout the product lifecycle.