What are the responsibilities and job description for the Quality Engineer position at Insight Global?
Insight Global is actively seeking a CAPA Quality Engineer to join its team. This position is essential to driving CAPA activities, ranging from issue identification closure, project management over CAPA activities, ensuring the quality of CAPA record content, and representing CAPAs during audits and CAPA review board meetings. This position to be home based in the USA, and the individual hired will facilitate product and process in Corrective and Preventive Action (CAPA) investigations, from issue identification to implementation of solution and effectiveness monitoring. This inividual will represent CAPAs during audits and CAPA Review Board meetings. They will lead and mentor cross functional teams with the implementation of appropriate root cause analysis techniques (e.g. Pride problem solving), analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances. This individual will need to work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available.
Salary: $51-$53 per hour
REQUIRED SKILLS AND EXPERIENCE
* Bachelor's degree plus a minimum of 3 years in a highly regulated environment as an engineer that has done CAPA's as part of their day to day job (auto, pharma, nuclear industries) * Understanding and application of global medical device regulations * Experience in Quality Management System processes (ISO 13485), including cross-sector or business process standardization, ensuring effectiveness and efficiency while maintaining compliance with worldwide regulations * An ability to successfully communicate and educate quality management system regulations, policies, and strategies to teams at all levels of the organization * Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions. * Advanced Analytical Skills; demonstrated ability to troubleshoot complex process/system issues
NICE TO HAVE SKILLS AND EXPERIENCE
* Masters degree * Experience working in Consent Decree situations, or FDA Warning Letters *PLUS IF THEY HAVE: ISO 13485, EU Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, ANVISA, ISO 14971, ISO 9001, and others including familiarity with the European Medical Device Regulation MDR 2017/745.
Salary : $51 - $53
