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 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 real difference.
The main responsibilities of the role are;
* 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
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
* Excellent facilitation, coordination, prioritising, and communication skills
* Proven ability to manage and prioritise work load, 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