Director

• Leading the development, establishment and maintenance of Quality Assurance and Engineering programs in the STS team.
• Define and influence a quality culture that enables both rapid transformation of ideas to requirements to products and diligent and deliberate compliance to internal quality management system requirements in design and development.
• Manage, mentor, and develop Quality Engineers on approach to design controls, agile design, risk management and product security.
• Build strong partnerships with cross-functional leaders to drive continuous improvement efforts, through facilitating, leading, and collaborating effectively.
• Manage and monitor day to day activities to ensure compliance with company policies and procedures (e.g. compliance with FDA, BSI, CSA, etc.).
• Align software validation practices across BD.
• Manage quality metrics and present them in management reviews.
• Provide Design and Development leadership during FDA and Notified body site inspections.
• Interface with the FDA on Pre-Market Activities: Design Controls, Risk Management, Test Methods, Safety Assurance Case, Human Factors.
• Maintain effective design-related Quality Metrics and define and execute activities to improve performance.
• Actively identify improvements to the processes within the QMS to enhance both compliance and quality.

Director of Software Quality

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