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Quality Engineer

Company: Comrise
Location: Leesburg
Posted on: August 6, 2022

Job Description:

Quality Engineer- TOP medical device manufacturing - 12 months+ contract-May go permanent- Healthcare benefits offered.
Works closely with operations and the business functions to ensure quality performance of product and processes.
--- Collaborates with Divisional QA, cross-functional, shared services and supplier's teams to address top quality issues.--- Participates in creation and/or review of new or modified procedures.--- Approval of quality records.--- Advocate of Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation.--- Applies statistical methods of analysis and process control to current operations in support of management review, CAPA, and other quality system processes.--- Serves as the GQO Quality representative on cross functional project teams.--- Critical assessment of internal and supplier proposed change management activities.--- Develops understanding of risk management practices and concepts and applies knowledge to manufacturing operations.--- Leads internal and supplier driven non-conformances and manage the timely closure of NC's.--- Leads CAPA projects and manage to timely root cause investigation, implementation and closure.--- Performs as subject matter expert for internal and external audits by regulatory agencies, notified bodies, competent authorities, etc.--- Leads quality system projects of a moderate scope and complexity.--- Dispositions non-conforming product within the material review board (MRB), issuing NC's as appropriate.--- Maintains KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.--- Collaborates with appropriate stakeholders to identify and execute opportunities for supplier part certification as required.--- Supports the creation and maintenance of inspection methods and sampling.--- Supports the development and improvement of the manufacturing processes for existing products.--- Supports PPAP activities for supplier changes.--- Leads execution and analysis of manufacturing related complaints and product field actions.--- Supports the development and review of process and equipment validation/qualification and MSAs.--- Executes internal quality deliverables associated with engineering changes, manufacturing transfers and supplier-initiated changes.--- Supports manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
In addition, looking for someone with:--- Experience working in a manufacturing environment.--- Custom gage design experience and understanding of GD&T--- Experience with implant/instrument cleaning processes. Specifically, an understanding of ISO 19927.

Keywords: Comrise, Leesburg , Quality Engineer, Engineering , Leesburg, Virginia

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