Director, Quality Assurance and Regulatory Affairs

Summary

Join Noah Medical, a leading medical robotics company, as their Director of RA/QA. Reporting to the Head of Quality and Regulatory, you will lead the RA/QA function, providing guidance and leadership in regulatory and quality aspects throughout product development. You will establish departmental objectives, manage staff, and develop company policies. This role involves regular interaction with senior management and external stakeholders. You will support the implementation and maintenance of the quality management system (QMS), coordinate regulatory activities, and manage complaint investigations. The ideal candidate possesses a BS in Engineering or Technology, 10+ years of RA/QA experience in medical devices, and 3+ years of supervisory experience. Noah Medical offers a comprehensive benefits package including competitive pay, health insurance, 401K, stock options, tuition reimbursement, paid time off, and flexible work arrangements.

Requirements

• 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

Responsibilities

• 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
• Serves as the designated Management Representative

Preferred Qualifications

• Knowledge of sterile/disposable medical device production processes
• Master Degree, MBA, experienced with Software Validation
• Certifications is a plus: CQE, CQA(BM), CQM, 6 Sigma, ISO Auditor, etc

Benefits

• Competitive Salary
• Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options
• Equity & Bonus Program
• Life Insurance (company paid & supplemental) and Disability insurance
• Mental health support through medical insurance programs
• Legal and Pet Insurance
• 12+ paid holidays, 15-20 days of PTO + sick time
• Paid parental leave
• In-office snacks and beverages
• In-office lunch stipend
• Learning & Development Opportunities: On-demand online training and book reimbursement
• Team building and company organized social and celebration events
• Noah Medical may offer remote, hybrid, or onsite work arrangements within the state of California depending on the specific team and/or role where applicable