• Acceptance Activities • External Manufacturing • Incoming Quality • Corrective and Preventative Action (CAPA) • Internal and External Audits • Supplier Qualification • Document/Record Controls • Environmental Monitoring | • Process/Test Method Validation/Equipment Validation • Technology Transfer • In process Quality • Project Leader • Nonconforming Product (NCR) • Production and Process Controls • Quality Systems • Process Excellence Six Sigma |
Drive quality improvements, initiatives and leadership within operations. Develop and implement technical QA protocols/methods for PI and PM. Provide PA and input to manufacturing management.
Provide operational performance measures for the quality function and participate/champion improvement teams to drive process and quality improvement.
Perform process investigations and troubleshooting for all applicable manufacturing processes. Support operations in corrective action planning and execution.
Provide technical and quality engineering input within operations and quality. Develop and validate (IQ, OQ, PQ) manufacturing process for medical device. Responsible for generating and maintaining all paperwork associated with process development, including, but not limited to, notebook studies, process verification protocols and reports, process validation protocols and reports, process FMEA and manufacturing instructions and routers. Thorough working experience on QSR, GMP, Statistics, Validations, IQ/OQ/PQs, PPAP, APQP, DOE, FMEA, ISO 9000, QS-9000, ISO 14001 and ISO 13485.
Develop and implements intermediate and advanced problem solving tools. · Implement SPC and IC for analyzing and monitoring data to evaluate, improve process and product performance.
Lead the implementation of process improvement projects within the business goals. Lead and participate process validation activities.
Fully support the implementation of new manufacturing processes. · Continuously drives a culture of continuous improvement and reinforce the elimination of process variation.
Coordinated project work among cross-functional project participants ensuring clear accountability and understanding of roles and responsibilities.
Liaison with suppliers as needed to ensure product quality and process performance.
Develop, implement and validate suitable process and product inspection and measuring applications.
Communicate significant issues or developments identified during quality activities and provides recommended process improvements to management.
Identify opportunities to improve manufacturing processes and deliver improved product quality.
Lead and participate in risk assessment activities.
Train, coach and mentor operational and quality in process technology and lean/six sigma tools/techniques as required.
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