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Participation and facilitation of QMS Systems, including: Complaint Investigations, Corrective and Preventative Actions, Non-Conforming Material Reports, Change Management, Risk Assessments, Internal Audits and support of client audits.
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The candidate will have demonstrated proficient experience with quality engineering concepts, including but not limited to design control, risk management, supplier quality, and continuous improvement.
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The Quality Engineer will utilize inspection/test results, data analysis, customer feedback, key process indicators, Internal Audit results, and risk analysis tools to identify non-conformities and/or potential non-conformities within product and/or processes.
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Hands-on experience with medical device hardware and software lifecycle processes and risk management, including verification and validation activities. Drive the Risk Management process and associated activities.
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Your experience in contract review, risk management, and collaborative engagement with cross-functional teams. You have a background in quality engineering and quality management within the defense industry, and also in a production/manufacturing environment.
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Process Continuous Improvement, SPC, Six Sigma, GD&T, Inspection, PPAP, Risk Management, Supplier Quality Audits, PFMEA, Process Continuous Improvement, SPC, Six Sigma, GD&T, Inspection, PPAP, Risk Management.
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Ensure design requirements are met: own quality engineering design control deliverables and maintain product Design History Files (i.e. Design input/output documentation, Risk management tools.
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Risk Management: Develop and implement risk management strategies related to supplier processes, identifying and mitigating potential risks to product quality, patient safety, and regulatory compliance.
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Ownership toclose CAPA, driving risk management activities. MedicalDevices Risk Management. Experience inPost-Market-Surveillance, Complaint Management of Medical Device.
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The primary emphasis of the Supplier Quality Engineer is to assist with managing product quality through the implementation of supplier/contract manufacturer evaluation procedures, use of risk management tools, and auditing of current and prospective vendors.
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Lead risk management activities from product concept through commercialization. The Sr. Design Quality Engineer will serve as a technical representative providing design quality expertise to product development teams and is responsible for maintaining a strong collaborative partnership with cross-functional team members to achieve patient / user safety, customer satisfaction, and organizational success.
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We are seeking a Quality Engineer at our headquarters in Duncan, SC. The Quality Engineer (QE) will be a key contributor to creating and sustaining a data-driven, closed-loop quality system and the efficient management and continuous improvement of the quality system and key business processes.
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Management of PPAP samples and PPAP filing system. While performing the duties of this job, the employee is constantly exposed to moving mechanical parts, fumes or airborne particles, risk of electrical shock, and vibration.
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Collaborates with software development teams in the creation of Design History Files (DHFs) including software development plans, software verification and validation plans, software requirements specifications, software architecture and design documents, design and code reviews, software Risk Management File (RMF), test protocols and reports, traceability matrices.
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Proficiency in Risk-Based Test Management and Test Automation - Tosca, Performance Testing, Regression Testing, Disaster Recovery Testing, and Data Migration Testing. · 5 or more years of experience in testing various channels of Account Management; Case Management; Payments using Credit Cards and ACH at a minimum, Digital Wallets is desirable; and Disputes.
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risk management jobs Title: quality engineer
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