Quality Engineer - NCR/CAPA

Terumo Aortic; Renfrew; On-site; GBP 45,000 - 65,000; Full time

Job summary

Terumo Aortic is recruiting a Quality Engineer (NCR/CAPA) to support NCR/NCR processes and CAPA activities within a regulated medical device environment in the United Kingdom.

You will develop containment and investigation plans, conduct root‑cause analysis, and drive corrective actions with cross‑functional teams to ensure timely closure and robust documentation.

Qualifications

• Relevant science/engineering degree required.
• Six Sigma Green Belt or higher is preferred.
• Experience with Non-Conformance, CAPA, RCA and trending.
• Knowledge of regulatory standards for medical devices is desirable.

Responsibilities

• Maintain CAPA/NCR processes including containment plans and root cause analysis.
• Develop investigations, action plans and effectiveness verification.
• Provide guidance on CAPA/NCR investigations and documentation practices.
• Lead CAPA/NCR and NCR teams through all phases from initiation to closure.
• Support trend analysis and KPI reporting for QMS dashboards.
• Collaborate across functions to ensure containment actions and communication.
• Contribute to dFMEAs/pFMEAs with QE input and risk assessment.
• Identify process improvements using Lean or operational excellence tools.
• Support internal audit programs and regulatory readiness.

Skills

Quality engineering

NCR/CAPA knowledge

Root cause analysis

Regulatory compliance

Lean methodology

Education

Relevant science/engineering degree

Tools

Minitab

Job description

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.

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.