Quality Engineer

Quality Engineer - CSV

Ref: 197| Posted: 31st Jan 2024

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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