Vice President of Quality

This is a senior executive opportunity for a quality leader who thrives in building, scaling, and leading world-class quality organizations. The Vice President of Quality Assurance will own the company’s quality strategy and execution, ensuring regulatory compliance, product safety, and operational excellence across the full product lifecycle. This role partners closely with executive leadership and cross‑functional teams to support innovation, risk‑based decision making, and continuous improvement in a dynamic, growth‑oriented environment.

• Own and evolve the organization’s quality management system in alignment with U.S. and international medical device regulations.
• Serve as the senior quality leader interacting with regulatory authorities and external auditors.
• Ensure audit readiness and effective execution of regulatory inspections and third‑party assessments.
• Oversee complaint handling, post‑market surveillance, and corrective and preventive action activities.

• Lead, mentor, and scale a high‑performing quality organization.
• Foster a culture of accountability, collaboration, and continuous learning.
• Partner with operations, engineering, and executive leadership to align quality objectives with business goals.
• Provide quality leadership from early concept through commercialization.
• Embed risk‑based thinking into design, development, and manufacturing processes.
• Ensure quality systems are efficient, scalable, and supportive of innovation.
• Establish quality metrics and use data to drive decision making and improvement initiatives.
• Lead efforts focused on process optimization, defect reduction, and operational excellence.
• Ensure timely resolution of quality issues to minimize regulatory and business risk.

• Drive initiatives that ensure products meet high standards for safety, reliability, and performance.
• Leverage customer feedback and post‑market data to strengthen product quality and brand reputation.
• Promote quality awareness and engagement across the organization.

• Bachelor’s degree in Engineering, Science, Regulatory Affairs, or a related discipline (or equivalent experience).
• Significant senior‑level experience leading quality and/or regulatory functions in the medical device industry.
• Deep expertise with U.S. and international quality system regulations and standards.
• Proven track record of building and improving quality systems in fast‑paced, evolving environments.
• Strong executive presence with the ability to influence across functions and at the leadership level.
• Hands‑on, pragmatic leadership style with strong attention to detail.
• Excellent communication skills, including the ability to clearly convey risk, strategy, and performance.

• Executive‑level influence with direct impact on product quality and patient safety.
• Opportunity to shape and scale quality systems in a growing organization.
• High visibility with leadership and meaningful cross‑functional collaboration.
• Role designed for a leader who wants both strategic ownership and hands‑on impact.
• Strong compensation, bonus and equity offered.

Executive

Full‑time

Quality Assurance and Engineering

Medical Equipment Manufacturing