Terumo Aortic are currently looking to recruit a CSV Quality Engineer to join our Quality Assurance Engineering team. This is a fantastic opportunity to make a real difference in our global business during a time of investment and growth.
The main responsibilities are;
- Provide consultation and support IT and Quality Projects
- Provide Quality representation on IT project teams
- Provide consultation and support to the development of CSV test protocols and reports, validation plans and IQ/OQ/PQ rationales
- Provide Quality support as required to assist with protocol execution and/or oversight
- Provide Quality support and resource to assist with complaint and CAPA investigations and resolution
- Ensure root cause investigations are carried out in response to reported product defects
- Analyse and approve corrective actions proposed to address quality issues
- 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
- Develop training materials for design and manufacturing teams with respect to CSV validation requirements
- Maintain the Computerised System Validation (CSV) inventory
- Carry out periodic CSV reviews according to the schedule
- Perform validation and review of Quality Owned Systems
- Provide support to SMEs in implementation of Computer System Validation
- Work towards meeting departmental and facility objectives
- 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
- Assume other responsibilities from time-to-time to support the plant’s strategic plan and personal career plans
The successful candidate will possess;
- Relevant science/engineering degree
- Experience in a global company within a regulated industry, preferably medical device or pharmaceutical manufacturing
- Experience of GAMP 5, GxP assessment and validation of computer systems
- Strong computer skills and industry knowledge
- 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
- Must be able to work cross functionally and develop effective relationships in support of the manufacturing process
- Must be able to influence change with objective information and well-structured communications