Leo Cancer Care: Quality Engineer Level III

Position Title: Quality Engineer Level III Reports to: Global Manager Regulatory Affairs & Quality Assurance FT/PT : FT On-Site   Position summary  The Quality Engineer is responsible for ensuring that Leo Cancer Care's products, processes and quality management systems consistently meet applicable regulatory requirements, recognized standards and internal quality procedures.   The role supports the implementation, maintenance and continuous improvement of the Quality Management System in accordance with ISO 13485, EU MDR, UK MDR applicable FDA requirements, alongside additional country specific requirements when required.   Working closely with Engineering, Manufacturing, Regulatory Affairs and other relevant stakeholders, the Quality Engineer leads and supports quality investigations, non-conformances, CAPA, change control and post-market quality activities to ensure product safety, performance, compliance and continuous improvement throughout the product lifecycle acting as quality champions and leading the quality mindset.   Key responsibilities - Quality Management System (QMS) - Support the implementation, maintenance and continuous improvement of the Quality Management System in accordance with ISO 13485 and applicable regulatory requirements. - Develop, review and maintain quality procedures, SOPs, work instructions, forms and associated quality records. - Ensure effective document control and management of quality records. - Support the implementation and monitoring of Quality Objectives and Key Performance Indicators. - Identify opportunities to improve QMS effectiveness and operational efficiency. - Ensure quality processes are consistently implemented across the business.   - Non-Conformances / CAPA and Audit Management (internal and external) - Manage and investigate (and own when applicable) internal and external non-conformances and CAPA’s ensuring appropriate containment, correction and resolution, Inc. effectiveness - Lead and support root cause investigations using appropriate problem-solving methodologies. - Ensure corrective actions address identified root causes and are implemented within agreed timescales. - Support the planning and execution of internal quality audits. - Participate in supplier, customer and external regulatory or certification audits. - Ensure corrective actions arising from audits are appropriately implemented and closed. - Provide quality documentation and objective evidence to support regulatory inspections, audits and technical documentation reviews.   - 3. Risk Management - Support the implementation and maintenance of the product risk management process in accordance with ISO 14971. - Participate in product and process risk assessments, including Failure Mode and Effects Analysis (FMEA). - Review and assess risks arising from product changes, non-conformances, complaints and manufacturing issues.   - 4. Design and Development Quality - Provide quality input throughout design and development activities. - Support design reviews and ensure appropriate quality and regulatory considerations are addressed. - Review design verification and validation activities to ensure appropriate evidence is documented. - Ensure design changes are subject to appropriate review, approval and impact assessment. - Support design transfer activities to ensure products can be consistently manufactured and meet defined specifications. - Ensure design and development records are maintained in accordance with QMS requirements.   - Engineering Change Control / Verification and Validation - Review and support the assessment of proposed changes to products, components, software, processes and documentation. - Ensure changes are evaluated for potential quality, safety, performance and regulatory implications. - Support the identification of any required verification, validation, testing or risk assessment activities before implementation. - Ensure changes are appropriately documented, reviewed, approved and traceable. - Monitor the implementation of approved changes to ensure continued product conformity. - Support the development and review of validation and verification protocols and reports. - Review project documentation, protocols and reports for accuracy and compliance before submission. - Ensure appropriate quality oversight of process validation and equipment qualification activities. - Support the validation of software and automated processes where applicable. - Review objective evidence to ensure acceptance criteria have been met. - Ensure validation activities are appropriately documented, approved and maintained. - Support revalidation assessments following relevant product, process or equipment changes.   - Manufacturing and Product Quality - Support manufacturing activities to ensure products consistently meet approved specifications and quality requirements. - Review and support the development of inspection plans, acceptance criteria and quality controls. - Investigate manufacturing defects, process failures and product non-conformances. - Support incoming, in-process and final product inspection activities, as applicable. - Review production and test data to identify trends, recurring issues and opportunities for improvement. - Support product release activities by reviewing all applicable test reports and relevant quality evidence before device release, within assigned authority. - Ensure appropriate controls are established to prevent the use or release of non-conforming products.   - Supplier and External Provider Quality - Support supplier quality management and the ongoing monitoring of supplier performance. - Assist with supplier evaluations, qualification and audits where required. - Assist with the investigation of supplier-related non-conformances and monitor associated corrective actions. - Assess the quality impact of supplier, material and component changes. - Work with the Supplier Development Engineer and relevant subject matter experts to resolve supplier quality issues. - Support the development and maintenance of supplier quality requirements and agreements.   - Complaints and Post-Market Quality - Support the investigation and resolution of product-related complaints. - Review complaint data to identify recurring issues, emerging trends and potential product risks. - Ensure complaint investigations are appropriately documented and linked to relevant non-conformances, CAPAs and risk management activities. - Support post-market surveillance activities and the evaluation of product performance. - Provide quality input into vigilance assessments and field safety corrective actions, where required. - Ensure post-market feedback is considered as part of ongoing product and process improvement. - Quality Data and Continuous Improvement - Monitor and analyse quality metrics, including non-conformances, CAPAs, complaints and audit findings. - Prepare quality reports and communicate trends and areas of concern to relevant stakeholders. - Identify opportunities to improve product quality, process efficiency and QMS effectiveness. - Support continuous improvement initiatives across Engineering, Manufacturing, Operations and other business functions. - Promote a proactive quality culture focused on prevention, accountability and continual improvement.   - Training and Cross-Functional Support - Be on-site to provide quality guidance and support to employees across relevant business functions. - Support the development and delivery of quality-related training. - Promote awareness of applicable quality procedures, regulatory requirements and product quality expectations. - Provide technical quality input into projects, product development activities and business improvement initiatives. - Escalate significant quality concerns, compliance risks and potential product safety issues to the appropriate management personnel. - Relevant Knowledge and Skill requirements The role requires an engineering or science degree, or demonstrated equivalent technical knowledge and experience, with a minimum of 5 years' experience in a Quality Engineering or Quality Assurance role within an engineering environment, preferably within the medical device sector or other regulated environments. The post holder should have a strong understanding of ISO 13485, ISO 14971 and applicable medical device regulatory requirements, including EU MDR, UK MDR and FDA requirements. Experience in QMS maintenance, non-conformance management, CAPA, root cause analysis, risk management, engineering change control and product quality is essential. Strong analytical, problem-solving and communication skills are required, together with the ability to work collaboratively across multidisciplinary teams. The post holder should be confident working with Engineering, Manufacturing, Regulatory Affairs, suppliers and other internal stakeholders to investigate quality issues, identify and implement effective corrective actions, support audits, assess product and process risks, and drive continuous improvement throughout the product lifecycle. About Leo Cancer Care Cancer is one of the biggest killers that we face today with 1 in 5 people diagnosed at some point in their life, it is something that affects us all. 50% of all patients diagnosed with cancer should receive Radiation Therapy as part of their treatment but due to the cost, size and complexity of current technology, the number that do is around half of that. Current Radiation Therapy is delivered with a patient lying supine on a table while a large machine is rotated around them delivering radiation from different angles to kill the tumor. Lying on a table, many patients report that they feel like a passenger in their treatment feeling vulnerable through the entire process. Leo Cancer Care was founded with one clear goal, to bring a more human way to treat cancer and empower patients to face treatment on their feet. We are looking for an enthusiastic individual to complement our passionate team in their mission to revolutionizing cancer treatment. You can be part of a world class team, developing the treatments of tomorrow. Leo Cancer Care is helping make changes in Radiation Therapy by shifting to upright patient positioning, imaging and treatment. We do what we do to find a better way, a better way to treat cancer and create a paradigm shift in radiation therapy to benefit all. We will do this by improving the accessibility and medicine in cancer care globally, making cancer treatment a more human experience for all. Working in radiotherapy not only will you be driving change for the greater good, but you'll be working on products that span a large field of different disciplines. Ways of Working As a team we work at a fast pace, we collaborate openly providing everyone with the opportunity to make a difference very quickly. In today’s world we understand the importance of working remotely and flexibly to maintain a work life balance. Leo Cancer Care is dedicated to fostering a diverse and inclusive workplace environment. We embrace and celebrate the unique backgrounds, experiences, and perspectives of all individuals. We believe that diversity enriches our organization and strengthens our ability to innovate and excel. Discrimination or harassment of any kind will not be tolerated. We encourage all qualified candidates to apply and join us in our mission to create a respectful and equitable workplace for all. Leo Cancer Care is an equal opportunity employer.