Senior Quality Engineer (NCR/CAPA)

Terumo Aortic are currently looking to recruit a Senior Quality Engineer (NCR/CAPA) to join our team. This role will provide Quality Engineering support to the NCR/CAPA processes including development of containment plans / investigation plans / root cause analysis / action plans / effectiveness plans and perform NCR/CAPA trend analysis. This is an excellent opportunity to truly make a difference whilst enjoying excellent career development.

The main responsibilities of the role are;

• Maintain the management tools (trackers, electronic folder, etc) to ensure audit readiness
• Provide consultation and guidance on CAPA / NCR investigation, impact assessments, risk assessments, and ensure implementation of good documentation practices.
• Provide guidance and support for effective investigation and root cause analysis for new CAPAs / NCRs, working collaboratively with other functional areas as appropriate
• Act as CAPA team owner/facilitator throughout all phases of activities such as initiation, investigation, action plan and effectiveness
• Act as NCR team owner/facilitator throughout all phases of activities such as initiation, risk assessment, investigation and disposition.
• Provide guidance and support for effective implementation of corrective/preventive actions from CAPA / NCR investigations
• Provide guidance and support for robust effectiveness measurement of CAPA / NCR actions
• Maintain communication channels with the CAPA / NCR owners regarding time frames and progression updates.
• Support development of solution verification tools to validate CAPA / NCR action plans
• Working with other functional areas as appropriate, ensure appropriate containment actions are defined and communicated
• Generate and maintain trending data for the CAPA / NCR process and publish as part of QMS KPI dashboard Provide trending data and reports upon request to senior management, functional managers, regulatory authorities and customers
• Provide data trending information and status updates to the respective CAPA and NCR Review Boards
• In conjunction with the Risk Team, provide QE input to dFMEAs and pFMEAs, particularly with respect to CAPA / NCR data
• Identifying opportunities to improve processes through use of Lean Methodology or operational excellence principle and tools.
• Work towards meeting departmental and facility objectives
• Participate in facility Internal Audit programme
  
  

The successful candidate will possess;

• Relevant science / engineering degree
• Six Sigma qualified – minimally Green Belt level (desirable)
• Knowledge and understanding of applicable regulations especially with regards to Non Conformance, CAPA, Root Cause Analysis and Trending
• Class III medical device knowledge (desirable)
• Proven experience of working in a global company within a regulated industry, preferably medical device or pharmaceutical manufacturing
• Working knowledge of Minitab or similar statistical tool (desirable)
• Experience of FDA 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
• Proven ability to manage and prioritise work load, meet deadlines and work in a pressurised environment
• Must be able to work cross-functionally and be able to lead teams CAPA / NCR Quality Engineers to complete appropriate CAPAs / NCRs to effective timely closure.
• Must be able to influence change with objective information and well-structured communications.
• Must be able to work cross-functionally and be able to lead teams Complaints quality Engineers and Investigators to complete appropriate complaints documentation for products and processes.