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Manufacturing, Validation, Site Automation, Engineer, Quality Control, and Global Technical Operations (GTS) associates. Employee will be required to work closely with Manufacturing, Validation, Site Automation, Engineer, Quality Control, and Global Technical Operations (GTS) associates.
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Monitor and analyze supplier performance metrics, identify areas of opportunity, communicate supplier risks, and drive the resolution of supplier quality issues and risk control processes.
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May lead this process under the guidance of Supplier Quality Manager and/or management representative. Comply with all applicable quality management system, environmental, safety and occupational health policies.
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Develop and establish effective quality control and support associated risk management plans, AFMEA, DFMEA and PFMEA. Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, Statistical Process Control (SPC), Design of Experiments (DOE), etc.
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Strong knowledge of quality control principles, methodologies, and tools (e.g., Six Sigma, Lean Manufacturing, Statistical Process Control. Develop and implement quality control procedures for both product manufacturing and process optimization.
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Assist in the integration of the risk management program with quality systems including, but not limited to, Validation, CAPA, Change Control, APQR, Complaints, and Inspection Readiness.
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Work with various Engineering groups or QA Manager to develop and execute plans including quality plan, risk management, Process Failure Mode and Effects Analysis (PFMEA), control plans, production part approval process (PPAP), part qualification checklist (PQC.
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May specialize in the areas of production control, product evaluation and reliability, inventory control and/or packaging as they apply to product or process quality. Supporting quality improvement projects through Corrective and Preventive Action (CAPA) process.
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Work cross-functionally with Manufacturing, Project Management, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering, Information Technology (IT), and Maintenance.
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Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.
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Conduct Data Analysis using SPC (Statistical Process Control) principles and Minitab. Utilize DOE (Design of Experiment), QSR (Quality Systems Regulations), and IQ/OQ/PQ (Installation Qualification, Operational Qualification, Performance Qualification.
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Quality Systems (Change Control, Non-Conformances, Requalification, etc) Foster change and innovation - Seeks solutions that strengthen quality, value, service, and effectiveness.
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Provide reports of findings and assure corrective action has been taken Lead and facilitate production non-conforming materials control process, Material Review Board, to reduce major scrap and rejects Develop and implement programs to reduce scrap, improve the first pass yield metric and reduce the cost of poor quality Work closely with Engineering, Supply Chain, and Operations on all stages of Engineering change orders and production deviations.
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Maintain clear and detailed records of qualification and change control activities for future compliance audits. Support the development and execution of technical commissioning and qualification documentation for complex, automated equipment and processes, in accordance with client's quality standards, current Good Manufacturing Practices, (21 Code of Federal Regulations Part 210, 211 and 820 level standards which apply to the equipment and product being validated) and national/international standards.
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