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Responsibilities:

• knowledge of basic quality tools, risk analysis, statistics (SPC), and inspection techniques
• Ability to read and understand engineering drawings
• Specific experience with process characterization, equipment IQ/OQ, process OQ, and PQ
• Specific experience with Test method Validation and Gage R&R
• Experience with root cause analysis and problem-solving for both technical and process issues
• Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485-2003
• Good problem-solving skills through the use of quality and statistical tools
• Ability to read and understand engineering drawings
• Knowledge of basic quality tools, risk analysis (PFMEA), statistics (SPC), Critical-to Quality (CTQ) Analysis
• Knowledge of Quality System requirements, ISO and FDA requirements
• Experienced with control procedures, such as the Change Management System, Nonconformance Reports, Engineering Specifications, Corrective and Preventive Action (CAPA), and Work Instructions & Proficient with Statistical Process Control concepts, process development, CNC programming terminology, and tooling design concepts
• Microsoft Office Suite and Project

Requirements:

• Analyze/review the effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
• Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality
• Develop, interpret, and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
• Collect data and execute/conduct various analytical/statistical analyses and interpretations as part of process improvements and day-to-day support.
• Document, justify, review, or analyze whether a proposed change to a process will not enhance the risk level in some way beyond the capability of current controls or whether a change will result in potential non-compliance to a required standard such as the QSRs
• Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine the effectiveness of these techniques on previously implemented improvements
• Interface with Manufacturing/Process Engineering, R&D, and Regulatory departments to resolve process issues and implement changes.
• Apply knowledge of process control tools, statistical sampling, and other analytical techniques to maximize the quality and flow of products through the production line.
• Identify, analyze, and manage risk through the product life cycle with the use of FMEA and other risk management tools.
• Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through the implementation of solution and effectiveness monitoring.
• Execute equipment qualification or process validation project(s).