Manager of Product Quality

Vicarious Surgical is a next generation robotics company developing a disruptive technology with the goal of increasing the efficiency of surgical procedure, improving patient outcomes and reducing healthcare costs.

As a Manager of Product Quality, you will manage quality functions including, but not limited to, Supplier Management, Manufacturing Quality, and Quality Control/Inspection by developing, establishing, and maintaining quality engineering methodologies, systems, and practices. This is a hands-on position requiring direct involvement with day-to-day quality tasks execution. This position will also drive product/process improvements with the objective of compliance, safety, and high customer satisfaction.  The expectation for this role is to be onsite for a minimum of 4 days per week. 

Responsibilities: 

• Supervision of quality inspection group.
• Ensure inspections are completed to support manufacturing and product development needs. Resolve nonconformances with appropriate corrections and/or corrective actions.
• Support manufacturing by ensuring all process variables and their interactions are adequately defined. Ensure all process failure modes have been identified and mitigated. 
• Oversee supplier selection and onboarding. Perform supplier evaluations as needed to assure supplier capabilities including the assessment of the adequacy of inspection methods, manufacturing practices, and control of quality procedures to deliver conforming products in a timely manner. 
• Lead supplier audits and work with suppliers to resolve audit findings and/or nonconformances.
• Approval of DCOs for product, process and quality system changes.
• Drive and implement plant wide quality system improvements.
• Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
• Validation: Define process and product validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
• MRB: Review of MRB trends and identification of appropriate corrective actions when required.
• Monitoring of key quality metrics in areas of responsibility to identify improvement opportunities.

Qualifications:

• 7+ years’ experience in FDA regulated Medical device industry. 2+ year of Supervisory experience.
• Minimum of a BS in Mechanical Engineering, Biomedical Engineering, Process Engineering, Analytical Chemistry, or equivalent degree.
• Strong knowledge of quality principles and the ability to utilize these methods in a manufacturing environment.
• Highly motivated and self-directed with a strong sense of urgency, with an ability to pull in resources from other departments as required.
• Excellent Communications Skills (oral, written, presentation) at different organizational levels.
• Regulated industry preferred.
• Experience with root cause analysis tools and methods.
• Working knowledge of defect avoidance methodologies such as poke yoke, DFMEA/PFMEA, DOE.
• ISO 13485 auditor certification preferred. 

Together, we share a love for learning, and we are passionate teachers.  As a company, we set ambitious goals and individually, we share in that ambition. At the office, we enjoy each other’s company during monthly social, catered lunches and company celebrations.