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Supplier Quality Engineer will be responsible for ensuring that purchased products produced meet quality standards required to minimize quality costs and maximize customer satisfaction while ensuring that procedures and processes are adhered to local and corporate Quality Management System.
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In addition, the Sr. Supplier Quality Engineer will work with teams to develop the supplier risk mitigation strategy with procurement and category management. The Sr. Supplier Quality Engineer is primarily responsible for supporting and sustaining robust Supplier Management programs for designated manufacturing and development activities.
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The Senior Quality Engineer (SQE) is responsible for defining the Quality baseline to reflect the Customer’s expectations and Quality Management System (QMS). Responsible to participate in Continuous Improvement projects to improve the effectiveness of the Quality Management System, associated processes, key performance metrics, cost of conformance and non-conformance, and overall cost savings.
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This individual will be responsible for providing operational management to develop, implement, and manage Quality Systems compliant with regulatory requirements, lead cross-functional teams, lead the process on design controls related to quality and process, risk management activities, complaint handling, CAPA, document control, supplier qualification and management, and auditing.
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ASQ Certified Quality Engineer, Six Sigma Black Belt. Risk Management Principles. Tabulates, analyzes, and reports quality system metrics used in operational management and quality system processes such as Internal Audit and Management Review.
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Lead the risk assessment and process capabilities for purchased items Knowledge of Statistical Process Control (SPC), Failure Mode & Effect Analysis (FMFA) application, Lean-Six Sigma and Measurement System Analysis.
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The Quality Engineer is the key resource for the use of statistical techniques and validation activities (e.g. statistical process control, risk-based sampling, Gage R&R, Test Method Validation (TMV), DOE, process characterization, validation, and capability studies.
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Establish systems to track/report/monitor the sterility assurance, validation and supplier management metrics and provides proactive recommendations for negative trends, process improvement and risk mitigation.
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Responsible for the implementation of Quality Risk Management in relevant aspects of the QMS Internal audit program and performance of internal audits. Directs and oversees Supplier Quality Management and performance of supplier audits as appropriate.
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Work with Product Line Engineers to complete post market risk assessments and drive periodic updates to risk management documentation and potentially other documents. Utilize applicable quality tools (Root cause analyses) to ensure timely, accurate, and complete failure investigations of product complaints leading to the root cause and ensure that all activities are documented in the complaint management system.
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The Quality Engineering subjects are Risk Management, Test Method Validation (TMV), Statistics, Reliability Engineering, Process Validation (PV). Support the quality management system as required.
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Experienced in Earned Value Management, Cost Account Management, and Risk and Opportunity Management. Ensure independent reviews and assessments of program performance are performed, including independent technical assessments of systems engineering, Quality Assurance (QA), lessons learned, technology, production and programmatic (cost, schedule, and risks) practices assuring Quality management System (QMS) processes are defined and implemented.
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Staff Manufacturing Quality Engineer provides quality assurance support for all aspects of New Product Introductions (NPI), including Design Controls/Transfer, Incoming /In-process control, Risk Management, and sustaining engineering.
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What you will do:Responsible for Supplier Quality risk management. Responsible for Supplier Quality risk management. Manages implementation of Supplier Quality processes, including supplier approval activities, source selection evaluations, supplier classification designation (Critical, Key and Standard), development and execution of supplier quality risk assessments and mitigation plans, and supplier quality requirements development and flow-downs.
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Technically responsible for product drawing reviews, process flow charts, design reviews and feasibility risk assessments including relevant documentation such as risk assessments, process flow, part criticality, BOM management, supplier establishment, environmental specifications, assembly & test tool assessments etc.
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risk management jobs Title: quality engineer
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