Director of Quality

Virtual Incision is advancing robotic-assisted surgery with a focus on expanding access to minimally invasive care. We are a growing medical technology company where experienced leaders have the opportunity to make a meaningful and visible impact.

Why Virtual Incision:

• Work on innovative robotic surgical technology with the potential to improve patient care.
• Join an experienced, collaborative team focused on clinical excellence and disciplined execution.
• Take meaningful ownership of products and programs in a hands-on environment.
• Work in a culture that values technical rigor, practical problem-solving, and teamwork.
• Competitive benefits including medical, dental, vision, disability and life insurance, 401(k), flexible working hours, and PTO.

Job Summary:

The Director of Quality is a highly engaged, hands-on leader responsible for the performance, effectiveness, and continuous improvement of Virtual Incision's Quality function. This role is responsible for ensuring that the Quality Management System (QMS) remains compliant, practical, scalable, and fully integrated into manufacturing and business operations.

The Director of Quality will work closely with Engineering, Manufacturing, Regulatory Affairs, Supply Chain, and Operations teams to ensure product quality, regulatory compliance, and manufacturing readiness while supporting commercialization, production scale-up, and continuous improvement efforts. The successful candidate will be comfortable operating strategically while remaining actively involved in quality system activities, investigations, audits, and problem-solving to ensure timely resolution of quality and compliance issues.

Responsibilities:

• Lead and maintain the effectiveness of the Quality Management System (QMS), ensuring compliance with applicable FDA regulations, ISO standards, and company procedures.
• Ensure disciplined execution and timely closure of core quality system processes including CAPA, Complaint Handling, Nonconforming Material Control, Document Control, Training, Internal Audits, and Management Review.
• Review and approve Change Requests, CAPAs, complaint investigations, and nonconforming material records as appropriate.
• Provide hands-on leadership for investigations, root cause analyses, corrective actions, and preventive actions related to product, process, supplier, and quality system issues.
• Partner closely with Manufacturing and Operations teams to ensure quality requirements are integrated into production processes and continuously improved.
• Support design transfer, product commercialization, manufacturing scale-up, and process validation activities.
• Collaborate with Engineering teams to ensure product and process changes are implemented in a compliant and effective manner.
• Lead supplier quality activities, including supplier monitoring, quality performance assessment, risk management, and issue resolution.
• Ensure effective management of nonconforming materials and product disposition decisions.
• Participate in Complaint Review Board, CAPA Review Board, Material Review Board, and other quality governance activities.
• Monitor quality metrics, identify trends, assess risks, and drive improvements that enhance product quality and QMS effectiveness.
• Lead internal audits and support customer, certification, and regulatory audits and inspections, including preparation, execution, response, and follow-up activities.
• Present quality records, quality metrics, and quality system performance during audits, inspections, and management reviews.
• Partner with Regulatory Affairs to support inspections, regulatory submissions, and compliance initiatives.
• Develop and improve quality procedures, processes, metrics, and systems to support organizational growth and operational excellence.
• Foster a culture of quality, accountability, compliance, and continuous improvement throughout the organization.
• Build and develop a high-performing Quality team while establishing clear priorities, expectations, and accountability.
• Establish strong cross-functional relationships and ensure alignment between Quality, Manufacturing, Engineering, Supply Chain, and Regulatory Affairs.
• Drive continuous improvement initiatives that improve product quality, manufacturing performance, and overall business effectiveness.

Qualifications:

Required

• Bachelor's degree in Engineering, Quality, Manufacturing, Life Sciences, or a related technical discipline.
• 10 years of progressive Quality Assurance and Quality Systems experience within the medical device industry or another highly regulated industry.
• 5 years of quality leadership experience with responsibility for quality systems, compliance, and team development.
• Demonstrated experience developing, implementing, maintaining, and improving Quality Management Systems.
• Strong experience with CAPA, complaint handling, internal audits, supplier quality, document control, training, and nonconforming material management.
• Experience supporting manufacturing operations, design transfer, commercialization, and operational growth initiatives.
• Experience leading customer, certification, regulatory, and internal audits.
• Strong knowledge of FDA Quality System Regulations, ISO 13485, ISO 14971, and Good Manufacturing Practices (GMP).

Preferred

• ASQ Certified Quality Engineer (CQE), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or similar certification.
• Experience with robotic, electromechanical, or Class II/III medical devices.
• Experience in a startup, growth-stage, or rapidly scaling medical device environment.
• Experience supporting FDA inspections and international regulatory audits.

Knowledge, Skills & Abilities

• Strong technical expertise in medical device quality systems, compliance, and risk management.
• Demonstrated ability to drive measurable improvements in product quality, operational performance, and QMS effectiveness.
• Strong root cause analysis, problem-solving, and decision-making capabilities.
• Excellent communication and cross-functional leadership skills.
• Ability to influence stakeholders at all levels of the organization.
• Strong organizational and project management skills.
• Ability to thrive in a dynamic, fast-paced environment while maintaining attention to detail and regulatory compliance.

Salary: DOE

Status: Exempt

Virtual Incision is an Equal Opportunity Employer and values diversity in its workforce.