Terumo Aortic is currently seeking a dynamic and experienced Engineering Lead - Complaints to join our Quality Assurance team. In this critical role, you will oversee all aspects of our complaints processes and lead a dedicated team of professionals to ensure compliance with global regulatory standards, including EU Medical Device Regulations, ISO 13485, and FDA CFR 21 820.

Key Responsibilities;

The successful candidate will

• Manage and maintain all aspects of the Complaints processes, ensuring compliant procedures and methods in place for all related activities
• Conduct, evaluate and provide guidance on root cause investigation, impact assessments, risk assessments and general good Complaints practices, ensuring that robust containment plans are implemented and that issues are adequately documented, investigated resolved and effectiveness checks completed
• Provide support and resource to other functional areas to assist with Complaints investigations and resolution
• Approves complaints and decision reports within stipulated timeframes
• Work collaboratively with other functional areas to effectively investigate and resolve product and process quality issues, deploying appropriate tools to assist root cause analysis and risk assessment
• Generate and maintain trending data for the Complaints processes and publish as part of QMS KPI dashboard
• Provide trending data and reports upon request to senior management, functional managers, regulatory authorities and customers
• Develop and perform Health Risk Assessment (HRA) process and documentation, ensuring criteria and triggers for initiation of a HRA are clearly defined
• Manage Complaints Review Boards, creating updated presentation materials and meeting minutes
• Manage and develop Complaints team members to deliver effective and compliant processes, including the timely closure of quality events
• Provide input to dFMEAs and pFMEAs as appropriate
• Champion the deployment and use of selected electronic system for the management of all Quality events
• Develop and deliver training materials for Complaints
• Work towards meeting departmental and facility objectives
• Development of effective internal and external customer relationships to ensure quality and regulatory compliance for the business
• SME for Complaints during External audits

 Qualifications & Experience

• Relevant science/engineering degree or equivalent
• Six sigma qualification preferred
• Proven experience in Quality Management Systems in a similar role within a medical device environment
• Clinical Knowledge of cardiovascular implantable devices and techniques desirable
• Extensive experience in a global company within a regulated industry, preferably medical device or pharmaceutical manufacturing
• Experience of FDA regulations
• Knowledge and understanding of applicable regulations especially in relation to MDR/MIR reporting
• Thorough knowledge of regulatory standards, Quality Management Systems and global regulations for medical devices
• Strong analytical and problem-solving skills, including appropriate use of statistical techniques
• Excellent facilitation, coordination, prioritising, presentation and communication skills
• Proven ability to manage and prioritise work load, meet deadlines and work in a pressurised environment
• Competence in the use of IT technology, such as Microsoft Office applications, and ability to learn other IT systems used in the QA department
• Must be able to communicate and liaise cross functionally to develop effective relationships with other functional departments
• Must be able to influence change with objective information and well-structured communications