Director, Quality Assurance and Regulatory Affairs

Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple indications. We are looking for exceptional engineers and key team members. Our incredibly talented team of engineers, innovators, and industry leaders bring years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics, and Hansen. We are looking for talented, motivated and ambitious team members to revolutionize robotic surgery.

The Director of RA/QA reports to the Head of Quality and Regulatory. This position is the day to day leader of the RA/QA function and provides guidance and leadership from a Regulatory and Quality perspective to the team throughout all stages of product development.  We are looking for someone that is highly motivated in their career growth (possible vertical and horizontal growth to take on wider roles as well); must be a self-starter, team builder, and excellent in communication.

• Establishes RA/QA department operational objectives/budgets, manages staff hiring, assignments, performance feedback, and coaching to support company milestones. 
• Involved in developing, modifying and executing RA/QA related company policies, which affect immediate operation(s) and may also have company-wide effect. 
• Manages the RA/QA department functions through direct reports or subordinates.
• Regularly interacts with senior management of other functional areas, suppliers, and/or customers using soft skills to collaborate, think outside of the box, problem solve and gain acceptance of others in sensitive situations. 
• Supports defining, training and implementing the quality management system (QMS) at Noah Medical and the ongoing maintenance of the QMS to ensure that the quality system is properly documented and revised as necessary to assure continued compliance with US and International regulatory requirements.  
• Coordinates the planning and organization of regulatory activities related to Design/Development/NPI, manufacturing, distribution control, and service
• Manages the reporting and investigation of customer/service complaints, the review of corrective actions and failure investigations, the review of Post Market Surveillance reporting and, if necessary, implements field corrective actions. 
• May serve as the designated Management Representative. 

• Requires a BS (preferably in Engineering or Technology) with a focus in Mechanical, Industrial, Manufacturing, Electrical, Life Sciences, etc. 
• Minimum of 10 years of RA/QA related experience in the medical device field (experience in capital equipment and services a plus)
• Minimum of 3 years of supervisory experience of multiple exempt level employees.
• Experience working in a startup environment to meet rigorous timelines with NPI and product launch teams.
• Experienced in implementing a complete QMS system to meet US FDA and ISO requirements.
• Experienced in conducting internal and supplier audits and hosting 3rd party audits.
• Must be a self-starter, team builder, and excellent in verbal and written communication.
• Preferred: Knowledge of sterile/disposable medical device production processes.
• Preferred: Master Degree, MBA, experienced with Software Validation, 
• Certifications is a plus: CQE, CQA(BM), CQM, 6 Sigma, ISO Auditor, etc. 

#LI-Hybrid

The Pay Range for this position is listed. Noah Medical offers a comprehensive benefits package including: competitive pay, health insurance, 401K and stock purchase plans, tuition reimbursement, paid time off plus holidays, and a flexible approach to work with remote, hybrid, field or office work schedules. Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors such as location as permitted by law. Total compensation may also include additional forms of incentives.