Partner with cross-functional teams to identify product risks, investigate potential failure modes, and implement effective risk control measures.
Ensure compliance with ISO 13485, FDA regulations, customer requirements, and applicable quality standards.
Develop, review, and maintain quality procedures, SOPs, and documentation to support product development and Quality Management System (QMS) requirements.
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Prepare advanced samples, materials, equipment and other required tools for laboratory tests or development.
Perform comprehensive technical tests, analyse based on formulas and project requirements; tasks that require technical judgement.
Review and/or complete appropriate forms and documentation regarding research and development processes, tasks, results and conclusions. Draw conclusions and receive direction when required.
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