Director of Quality Assurance

• As head of a quality sub-function, the Director of Quality Assurance will interpret functional strategy to set goals and objectives for assigned team to ensure the quality of our products and operations
• This position will be leading the activities of building our quality policies for robotics product to be compliant with applicable medical device regulations
• As a key leader, this role takes part of strategic conversations and activities that include building a quality infrastructure aimed at transferring operations from concept to manufacturing in collaboration with robotics upper management and consultants
• An individual in this role will create and maintain the Quality Management System (QMS) and building the quality assurance team to promote quality principles across engineering, manufacturing, and elsewhere
• Serve as the quality management representative for the robotics business
• Provide strategic leadership of the quality system to ensure continued conformance to applicable domestic and international regulatory standards
• Ensure compliance with quality and regulatory requirements: 21 CFR part 820, ISO 13485, MDR 2017/745
• Coordinate and lead the definition of the quality and regulatory strategy, in collaboration with upper management and regulatory consultants
• Define, build, implement, and maintain the company QMS to support product development and company growth from concept through commercial launch; provide and conduct training for stakeholders as appropriate
• Provide support on quality and regulatory matters to critical suppliers
• Ensure the quality of our product development and verification/validation activities, including the compliance to applicable regulatory standards
• Grow and oversee the activities performed by a Quality team

Benefits

• Stock options
• 401k
• Health benefits
• Team events, competitions & activities

Qualifications & Requirements

• 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 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