Quality Lead - Product Quality

Engineering Lead - CSV Quality (Internal Candidates)

Ref: 208| Posted: 12th Sep 2023

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Terumo Aortic are currently looking to recruit a supplier Engineering Lead – CSV Quality to join our Quality Assurance Engineering team. This is a fantastic opportunity to join the business during an exciting time of growth and investment.

The main responsibilities of the role include;

  • Supervise assigned Quality CSV Engineers within their respective quality engineering team to ensure individual allocated tasks are met within agreed timescales, allocating tasks to team members as appropriate
  • The Engineering Leader (CSV) is responsible for ensuring functional excellence is maintained for the Quality CSV team reporting to them, through upgrading the skills and abilities of all personnel under his/her direct supervision
  • 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
  • In conjunction with other departments, support development of validated test methods
  • Champion the deployment and use of MasterControl 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 CSV validation requirements
  • Maintain the Computerised System Validation (CSV) inventory
  • Ensure periodic CSV reviews are carried out according to the schedule
  • Responsible for validation and review of Quality Owned Systems
  • Provide support to SMEs in implementation of Computer System Validation
  • Work collaboratively to create process-based procedures for CSV
  • Work towards meeting departmental and facility objectives
  • Participate in facility internal audit programme
  • 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
  • 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 GAMP 5, GxP assessment and validation of computer systems
  • Possess supervisory experience and strong interpersonal, planning and organisational skills
  • Strong computer skills and industry knowledge
  • 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
  • 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