Quality Assurance Engineer

Company: Comrise
Location: Leesburg
Posted on: January 12, 2020

Job Description:

Quality Engineer- TOP medical device company Responsibilities: Work closely with operations and the business functions to ensure quality performance of product and processes. Collaborates with Divisional QA, cross-functional and suppliers teams to address top quality issues. 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 Global, Compliance, and product development teams. Develop understanding of risk management practices and concepts and applies knowledge to manufacturing operations. Creation and/or review of new or modified procedures. Provides leadership and subject matter expertise in GQO Quality activities specific to labels and IFUs. Prepare and Review Engineering Change Orders for Regulatory compliance associated with labeling/IFU changes. Qualifications: Up to 10% travel required. Specific responsibilities to oversee the activities needed to complete product-labeling/IFU changes in support of global compliance requirements. High level of detailed accuracy is required. Excellent verbal, written and interpersonal communication skills. Excellent problem solving and analytical skills. Excellent technical writing skills. Requires project management skills and ability to influence without authority. Ability to multi-task and work independently as well as collaborate with teams. Ability to read and interpret engineering drawings and other technical specifications. Background knowledge of EU MDR is a plus.

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