Quality Engineer – NCR / CAPA in Inchinnan

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 a fantastic opportunity to join our business during a time of growth and investment on-site, offering fantastic career development opportunities and a chance to make a real difference.

Responsibilities:

• Maintain the management tools (trackers, electronic folder, etc.) to ensure audit readiness.
• 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.
• Work towards meeting departmental and facility objectives.
• Participate in facility Internal Audit programme.
• Development of cross-functional and collaborative relationships within the facility.
• Creating new policies or procedures to improve efficiency in CAPA/NCR handling.
• Development of effective internal relationships to ensure quality and regulatory compliance for the business.

Qualifications:

• 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.
• Excellent facilitation, coordination, prioritising, and communication skills.
• Proven ability to manage and prioritise workload, meet deadlines and work in a pressurised environment.
• Competent in the use of IT technology, such as Microsoft Office applications, and ability to learn other IT systems used in the QA department.