Terumo Aortic
Quality Engineer - NCR/CAPA
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Quality Engineer (NCR/CAPA) - Terumo Aortic
Terumo Aortic are currently looking to recruit a 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.
Main Responsibilities
- 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
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Requirements
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- 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.
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