Drive Proactive Continuous Improvement on Yield & Quality Metrics by designing templates for documents, file types, and document databases. Drive cross-functional teams to deliver continual improvement activities for internal processes deliverables.
Provide Supervision to Quality Assurance Inspectors and Technicians. Guide Quality Assurance operators, group leaders, and technicians in ongoing quality improvement activities
Bachelor’s Degree with 1 or more years of related experience is preferred. An equivalent combination of education and/or experience will be considered.
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Support PFMEA, SPC, and OCAP activities to identify process risks, monitor quality performance, and drive continuous improvement.
Collaborate with Production, Engineering, Purchasing, and Quality teams to resolve escalated issues and support customer and ISO 9001 audits.
Bachelor’s degree in Engineering, Quality, Manufacturing, or a related technical discipline, with 5+ years of relevant quality experience in a manufacturing environment.
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Support PFMEA, SPC, and OCAP activities to identify process risks, monitor quality performance, and drive continuous improvement.
Collaborate with Production, Engineering, Purchasing, and Quality teams to resolve escalated issues and support customer and ISO 9001 audits.
Bachelor’s degree in Engineering, Quality, Manufacturing, or a related technical discipline, with 5+ years of relevant quality experience in a manufacturing environment.
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Conducted supplier audits, qualification processes, and performance evaluations, including scorecard monitoring and continuous improvement initiatives.
Collaborated with cross-functional teams and suppliers to resolve quality issues, support supplier development, and ensure compliance with customer and regulatory requirements.
Strong understanding of supplier quality management, including NCR handling, RCCA/8D methodologies, and “Copy Exactly” principles.
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Develop verification and validation protocols and reports, applying advanced statistical techniques and ensuring compliance with global regulatory requirements.
Establish, review and maintain Design History File documentation, including design requirements, specifications and design outputs, ensuring inspection readiness.
Core team member of design change control activities, assessing product and process impacts while ensuring compliance and patient safety.
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Develop verification and validation protocols and reports, applying advanced statistical techniques and ensuring compliance with global regulatory requirements.
Establish, review and maintain Design History File documentation, including design requirements, specifications and design outputs, ensuring inspection readiness.
Core team member of design change control activities, assessing product and process impacts while ensuring compliance and patient safety.
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Documents all repairs and improvements on test equipment.
Monitors all testers for intermittencies and reduces them in accordance with targets set.
Provides support to Operations and the Test Engineers through participation in the continuous improvement effort and promotion of a "Quality First" mentality.
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