Quality Engineer

2 months ago

Pittsburgh, United States Insight Global Full time

Must Haves:

Bachelor’s degree plus a minimum of 5 years in the medical device or another regulated industry as a quality engineer or related

Understanding and application of global medical device regulations; FDA’s 21 CFR 820, 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.

Experience in Quality Management System processes, 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



Plusses:

Master's degree

Experience working in Consent Decree situations, or FDA Warning Letters

  • Experience using QMS software such as SAP


Day To Day:


Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring. Represent CAPAs during audits and CAPA Review Board meetings. 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. 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.

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