Quality Engineer – NCR

OverviewTerumo 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 real difference.ResponsibilitiesMaintain the management tools (trackers, electronic folder, etc) to ensure audit readinessProvide guidance and support for effective investigation and root cause analysis for new CAPAs / NCRs, working collaboratively with other functional areas as appropriateAct as CAPA team owner/facilitator throughout all phases of activities such as initiation, investigation, action plan and effectivenessAct as NCR team owner/facilitator throughout all phases of activities such as initiation, risk assessment, investigation and dispositionProvide guidance and support for effective implementation of corrective/preventive actions from CAPA / NCR investigationsProvide guidance and support for robust effectiveness measurement of CAPA / NCR actionsMaintain communication channels with the CAPA / NCR owners regarding time frames and progression updatesSupport development of solution verification tools to validate CAPA / NCR action plansWork with other functional areas as appropriate, ensure appropriate containment actions are defined and communicatedGenerate 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 customersProvide data trending information and status updates to the respective CAPA and NCR Review BoardsIn conjunction with the Risk Team, provide QE input to dFMEAs and pFMEAs, particularly with respect to CAPA / NCR dataWork towards meeting departmental and facility objectivesParticipate in facility Internal Audit programmeDevelopment of cross-functional and collaborative relationships within the facilityCreating new policies or procedures to improve efficiency in CAPA / NCR handlingDevelopment of effective internal relationships to ensure quality and regulatory compliance for the businessQualificationsRelevant science / engineering degreeSix Sigma qualified – minimally Green Belt level (desirable)Knowledge and understanding of applicable regulations especially with regards to Non Conformance, CAPA, Root Cause Analysis and TrendingClass III medical device knowledge (desirable)Proven experience of working in a global company within a regulated industry, preferably medical device or pharmaceutical manufacturingWorking knowledge of Minitab or similar statistical tool (desirable)Experience of FDA regulationsThorough knowledge of regulatory standards, Quality Management Systems and global regulations for medical devicesStrong analytical and problem-solving skills, including appropriate use of statistical techniquesExcellent facilitation, coordination, prioritising, and communication skillsProven ability to manage and prioritise work load, meet deadlines and work in a pressurised environmentCompetent in the use of IT technology, such as Microsoft Office applications, and ability to learn other IT systems used in the QA departmentSeniority levelEntry levelEmployment typeFull-timeJob functionQuality AssuranceIndustriesMedical Equipment Manufacturing #J-18808-Ljbffr