Head of Quality Systems and Quality Engineering

Lead validation engineering and quality systems teams to ensure systematic approaches are deployed to achieve compliance using efficient processes. Manage and support quality engineering group (validations, risk management, and equipment) to cover downstream validations, including sterilization, cleaning, reprocessing validations, manufacturing process validations, process capability assessment, and change assessment. Manage and build a team of quality-validation engineers and quality assurance professionals that ensure regulatory compliance across cross-functional teams (animal care, neuroscience, surgery, manufacturing (robot and implant), software, laboratories, and facilities). Communicate with experts to build and optimize processes to be efficient and compliant. Manage and support quality assurance group (Good Clinical Practices (GCPs), Good Laboratory Practices (GLPs), and Good Manufacturing Practices (GMPs)), including internal and external audits, regulatory requirement translation and adherence, document control, product release, and process quality. Ensure deviations and Corrective and Preventive Action (CAPA) are documented appropriately. Ensure optimization of all processes. 20-25% domestic travel from Fremont HQ to Austin office required.

• Master's degree or foreign equivalent in Regulatory Affairs, Biotechnology, or a related field;
• Four (4) years of experience as a Quality Manager, Quality Engineer, or related occupation;
• GCPs, current Good Manufacturing Practice (cGLPs), and current Good Manufacturing Practices (cGMPs) guidelines and regulations;
• Code of Federal Regulations (1 CFR 58 and 1 CFR 8 ) and quality management systems standards (ISO 13485 and ISO 9 1);
• Quality assurance audits: regulatory, document control, training, release, and process quality;
• Translating regulatory requirements into action and applying risk mitigation strategies;
• Quality engineering activities (validations, product design, and process capability);
• Identifying root causes and applying error proofing concepts; and building compliance systems, processes, and procedures.