16 of 16 ISO 13485 Jobs in the UK excluding London

precision, integrity, and a forward-thinking approach. You will act as the go-to subject-matter expert for all aspects of software regulation, including ISO 62304, ISO 82304, ISO 14971, ISO 34971, ISO 13485, ISO 27001, and AI-specific guidance such as ISO … notified bodies. Design and execute Qureight’s digital biomarker validation strategy in the US and EU markets. Provide expert guidance on software regulation, including ISO 62304, ISO 82304, ISO 14971, ISO 34971, ISO 13485, ISO 27001, and ISO 42001, ensuring all systems ...

analysis, and corrective/preventive actions. Collaborate effectively with production, engineering, and quality teams to ensure timely resolution of quality issues. Maintain compliance with ISO 13485 and other medical device regulatory standards. Contribute to Continuous Improvement efforts in Quality/Inspection processes and documentation. Increasing efficiency, improving … ability to interpret complex technical drawings and CAD data. Skilled in using a wide range of manual measurement tools. Familiarity with ISO 13485, ISO 9001, or other regulated quality systems. Good working knowledge of Quality documentation, including FAIRs, CTQs, inspection reports, NCRs, CAPA and Complaints. Strong teamwork ...

tests Experience converting requirements into structured test cases and procedures Experience working with medical devices running embedded software Working knowledge of IEC 62304 and ISO 13485 Good understanding of the full software engineering lifecycle Able to work independently and self-manage a standalone testing function Desirable Knowledge …/or ISO 14971 Contract Details 6 month initial contract, with potential to extend 3 days per week onsite in Manchester Up to £425 per day, Outside IR35 How to Apply If you have embedded software V&V experience within a regulated medical device environment and IEC 62304/ ...

Defining and improving firmware lifecycle processes, documentation, and audit readiness Working closely with Quality, Regulatory, and Systems Engineering teams Ensuring compliance with IEC 62304, ISO 13485, and medical device development standards Contributing to architecture, design reviews, risk management, and verification activities Mentoring engineers and supporting best‑practice adoption … regulated or safety‑critical domains (medical devices preferred but not essential) Strong understanding of structured development processes and documentation Familiarity with IEC 62304, ISO 13485, or similar compliance frameworks Ability to collaborate effectively with Quality & Regulatory teams A proactive mindset and confidence in leading technical direction Why Join ...

improve engineering processes and elevate team capability. Product Development Experience delivering hardware‐based products through a structured development lifecycle in a quality‐driven environment (ISO 9001, ISO 13485, or similar). Comfortable with verification, design reviews, configuration control, interface management, and risk assessment. Experience collaborating with manufacturing ...

embedded/firmware literacy Hands-on engineering mindset Experience in regulated or process-heavy industries (Medical devices, aerospace, automotive, nuclear, oil & gas) Exposure to ISO frameworks (ISO 13485 is a plus but not essential) Methodical, structured, documentation-first mindset Strong communicator and growth-oriented ...

patient safety principles An appreciation of electronics and hardware integration, beneficial rather than essential Familiarity with medical device standards and regulated pathways, for example ISO 13485, IEC 62304, ISO 14971, IEC 60601 and IEC 62366 Just as important as the person This is the part that will ...

safely with a minimum of downtime. Clinical equipment covered incorporates electrical, electronic, mechanical, computer software and medical gas systems. The department works to ISO 9001:2015 and ISO 13485:2016 quality standards and is responsible for the management of over 60,000 medical devices used across ...

internal and external engineers and scientists. Required Qualifications & Experience Regulated Industry Experience: 5+ years of experience in a regulated industry where Quality Systems (e.g., ISO 13485) are essential. Electromechanical Ownership: Proven experience owning complex electromechanical systems or subsystems through design, verification, and transfer to production. Verification & Validation: Strong ...

internal and external engineers and scientists. Required Qualifications & Experience Regulated Industry Experience: 5+ years of experience in a regulated industry where Quality Systems (e.g., ISO 13485) are essential. Electromechanical Ownership: Proven experience owning complex electromechanical systems or subsystems through design, verification, and transfer to production. Verification & Validation: Strong ...

contributing to scale-up, design transfer or NPI (New Product Introduction) projects in a medical device environment. Strong understanding of medical device regulations including ISO 13485, EU MDR, and FDA QSR/21 CFR Part 820. Proven experience with process validation methodologies (IQ/OQ/ ...

maintaining Quality assurance processes Ensure efficient, effective and compliant QMS process Overseeing compliant investigations, internal audits and change management Look to maintain the ISO13485 certification Experience or Qualifications – Quality Assurance Manager Degree educated in a relevant subject associated to engineering, medical technology or equivalent Knowledge of ISO 13485 ...

detail and communication skills Desirable Experience Medical device, diagnostics, IVD or MedTech experience Experience working in a regulated environment Knowledge of IEC 62304, ISO 13485 or similar standards Embedded software, system testing or hardware/software integration experience Experience mentoring junior engineers Why Apply? This is a chance ...

Strong understanding of software development lifecycle and version control (e.g., Git). Desirable experiences for an Embedded Software Engineer: + Experience with IEC 62304, ISO 13485, or FDA 21 CFR Part 820 + 3+ years of experience in a regulated industry Apply today to join a highly innovative ...

coaching-led, collaborative style - you assess how a team works before suggesting improvements, and you bring the team with you Experience in medical devices (ISO 13485, IEC 62304) or another heavily regulated, compliance-driven industry is a strong plus Exposure to embedded software development environments is beneficial ...

coursework deadlines Understand the Company’s obligation to quality and to apply the appropriate Standard Operating Procedures (SOPs) pertinent to the role. Comply with ISO 9001/13485 standards Understand the Company’s commitment to Health & Safety and ensure that policies, procedures and safe methods of work ...