1 to 3 of 3 Permanent ISO 13485 Jobs in the South West with Remote Work Options

reliability, and safety of medical devices throughout the development lifecycle. - Support the development of risk management documentation, in accordance with regulatory requirements such as ISO13485 and FDA guidelines. Qualifications: - Bachelor's degree in Engineering, Computer Science, or related field. Master's degree preferred. - Proven experience in systems engineering within the … medical device industry, including knowledge of regulatory requirements such as ISO 13485 and FDA guidelines. - Strong understanding of systems engineering principles, including requirements analysis, system design, integration, testing, and validation. - Excellent communication skills with the ability to collaborate effectively with cross-functional teams and stakeholders. - Experience with risk more »

ensuring timely delivery, effective resource allocation, and successful project outcomes. Global Perspective. Useful Qualifications/skills/experience Experience in a medical device company ISO 9001 ISO 13485 ISO 60601-1 ISO 14971 EU MDR FDA Medical Devices Why join us? Here at Smartbox, we more »

including non-conformities and CAPAs. Identify and implement process improvements. Depuitse for the Quality Manager as and when required. Key requirememts Detailed knowledge of ISO13485 and 21CFR Part 820 Quality System Regulation (QSR). 5+ years experience in a Medical Device Quality Engineering role. Experience in Risk Management tools and … techniques to ISO 14971. Experience in a design and development project team. Experience of change control. Knowledge of validation activities. Nonconforming product management, CAPA root cause investigation. Able to understand hardware and software requirements and specifications. Able to work collaboratively, with appreciation for all stakeholder requirements. Excellent communication skills … validation experience (process, equipment, cleaning, sterilisation, Test Method Validation). NPI. Knowledge of injection and extrusion moulding processes. Internal/Lead Auditor trained to ISO 13485. Knowledge of IEC 60601. The successful candidate for this role should be Organised and self-motivated. Detail-oriented with excellent communication skills. Open more »