Director of Quality Assurance

Join our team as the Director of Quality Assurance, where you will lead the development and implementation of our quality policies for robotics products, ensuring compliance with medical device regulations. You will create and maintain the Quality Management System (QMS), provide strategic leadership for the quality system, and oversee the activities of the Quality team. This role offers stock options, 401k, health benefits, and team events.

• Interpreting functional strategy to set goals and objectives for the quality assurance team, ensuring the quality of products and operations.
• Leading the activities of building quality policies for robotics products to be compliant with applicable medical device regulations.
• Creating and maintaining the Quality Management System (QMS), building the quality assurance team, and promoting quality principles across the organization.
• Strong knowledge of FDA requirements for design control of medical devices and 21 CFR 820; ISO 13485 and 14971; IEC 60601-1 and related regulations
• Preferred ASQ Certified Quality Engineer, ASQ Certified Reliability Engineer, and a Green Belt in one or more of the Process Excellence roadmaps (DMADVV, DMAIIC, or Lean)
• Excellent leadership and management skills
• Ability to comprehend principles of engineering, physiology, and medical device use
• New product development experience required
• Willingness to perform a “hands-on” troubleshooting and problem-solving activities
• Bachelor’s degree in engineering or related discipline and a minimum of 10 years of progressive responsibility in quality assurance in a medical device, regulated or robotics setting, plus a minimum of 3 years of prior people management experience; or equivalent combination of education and work experience
• Effective interpersonal skills with proactive leadership skills to determine deficiencies, communicate them effectively through the organization and follow through to resolution
• Good technical understanding of Design and Process Validation principles
• Ability to work effectively with employees at all levels of the organization
• Excellent verbal and written communication and presentation skills