Terumo Aortic requires an experienced Quality Engineer. The successful individual will be required to provide Quality Engineering support to various design or manufacturing led projects as well as supporting CAPA and Complaint investigations and root cause.
 

Key Duties

• Ensure that all related processes and procedures meet the requirements of all applicable regulatory standards; EU Medical Device Regulations; ISO 13485; FDA 21 CFR 820, Japan MHLW Ordinance 169, associated Canadian, Australian, Brazilian and Taiwanese regulations and others as appropriate.
• Promote a culture of high performance, continuous improvement and regulatory compliance with a commitment to quality.
• As part of a team of Quality Engineers, work as a multi-skilled group to support R&D, Manufacturing and Quality projects.
• Provide Quality representation on design teams and manufacturing process improvement teams.
• Provide consultation and support to R&D and Manufacturing in the development of test protocols and reports, validation plans and IQ/OQ/PQ rationale.
• Provide Quality Engineering support as required to assist with protocol execution and/or oversight.
• Provide Quality Engineering support and resource to assist with complaint and CAPA investigations and resolution.
• 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.
• Provide trending data and reports upon request to senior management, functional managers, regulatory authorities and customers.
• In conjunction with other departments, support development of validated test methods.
• In conjunction with the Risk Manager, provide QE input to improved dFMEAs and pFMEAs.
• Champion the deployment and use of Master control as the electronic tool for the management of all test protocols and reports, validation data, engineering change orders and any records associated with design review or project meetings.
• Develop training materials for design and manufacturing teams with respect to IQ/OQ/PQ validation requirements.
• Work collaboratively to create process based procedures for R&D and manufacturing in relation to design control, V&V and IQ/OQ/PQ and Computerised System Validation.
• Assist with validation plans for new tools, machines and processes.
• Work towards meeting departmental and facility objectives.
• Participate in facility internal and external audits as required.
• Development of cross functional and collaborative relationships within the facility.
• Development of effective internal and external customer relationships to ensure quality and regulatory compliance for the business.

Qualifications & Experience

• Relevant science/engineering degree.
• Six sigma qualified – green belt level (advantagous).
• Proven experience in Quality Management Systems in a similar role within a medical device environment.
• Extensive experience in a global company within a regulated industry, preferably medical device or pharmaceutical manufacturing.
• Extensive experience of project support to design and validation teams.
• Strong leadership experience including motivational management.
• Working knowledge of minitab or similar statistical tool`s.
• Experience of FDA/EU regulations.
• 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 work cross functionally and develop effective relationships in support of multiple R&D and manufacturing led projects.