Quality Engineer - NCR/CAPA

Terumo Aortic; Inchinnan; Sur place; GBP 42 000 - 62 000; Plein temps

Résumé du poste

Terumo Aortic is seeking a Quality Engineer (NCR/CAPA) to provide Quality Engineering support to NCR/CAPA processes, including containment plans, investigation plans, root cause analysis, action plans and effectiveness plans. You will develop and implement CAPA/NCR trend analyses and report to senior management.

The successful candidate will guide CAPA/NCR investigations, lead cross-functional teams, and help ensure robust documentation practices and continual process improvements within a

Qualifications

• Must have a science or engineering degree.
• Experience with CAPA/NCR processes and quality systems.
• Strong analytical and problem-solving skills required.

Responsabilités

• Maintain CAPA/NCR tracking tools and ensure audit readiness.
• Provide guidance on CAPA/NCR investigations and action plans.
• Lead CAPA/NCR activities across multiple functions and ensure timely closure.
• Support data trending and reporting for QMS KPIs.
• Contribute to risk assessments and dFMEAs/pFMEAs with QE input.

Connaissances

Analytical thinking

Problem solving

Cross-functional leadership

Statistical analysis

Formation

Relevant science / engineering degree

Outils

Minitab

Description du poste

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.