Drive Design for Manufacturability (DFM) and Design for Reliability principles, providing expertise in component design, tooling strategies, material selection, and biocompatibility considerations.
Lead process development and validation activities, including DOE, PFMEA, process capability studies, and IQ/OQ/PQ validation, utilizing scientific molding principles.
Ensure compliance with ISO 13485, FDA Quality System requirements, ISO 14971 risk management standards, and other applicable medical device regulations.
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· Responsible for daily production line audit, managing the document control process for Quality Management Systems in compliance with ISO 9001/14000 and TS 16949 quality standards.
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Supports multi-discipline manufacturing processes with respect to the repair, maintenance, installation and/or enhancement of a select group of machinery and equipment or interrelated systems.
Provides technical support in the area of chemical, electronic or mechanical operations, tests, experiments and/or problem resolution associated with components, parts, products or processes/systems.
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Dedication to Excellence: Set the gold standard for quality and operational success.
Job Overview
Customer centricity: Anticipate customer requirements, translate Voice of Customer (VOC) into measurable quality plans, and lead crisp communication during escalations.
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