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 #J-18808-Ljbffr