Vice President Quality & Regulatory Affairs

We are seeking a Vice President of Quality & Regulatory Affairs to lead quality and regulatory functions within a regulated medical device manufacturing environment. This individual will oversee the quality management system, ensure regulatory compliance, and build a culture of continuous improvement across the organization.

The ideal candidate brings progressive quality leadership experience in a contract manufacturing or custom manufacturing environment, with the ability to balance hands-on quality oversight with executive-level strategic leadership.

Key Responsibilities of the Vice President of Quality & Regulatory Affairs:

• Lead and continuously improve the Quality Management System (QMS) to ensure regulatory compliance and meet customer requirements.
• Oversee CAPA, nonconformances, root cause investigations, audits, and regulatory inspection readiness.
• Serve as the primary quality contact for customers, managing quality reviews, escalations, and compliance expectations.
• Partner with engineering and operations to support product development, process validation, manufacturing quality, and continuous improvement.
• Oversee regulatory activities and ensure quality systems remain aligned with evolving industry requirements.
• Lead, mentor, and develop the Quality & Regulatory team while promoting accountability and a strong quality culture.
• Contribute to executive-level decisions involving quality risk, customer relationships, operational performance, and business growth.

Qualifications of the Vice President of Quality & Regulatory Affairs:

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline, or equivalent experience.
• 10+ years of progressive quality experience in a regulated manufacturing environment, including at least 5 years in a leadership role.
• Strong working knowledge of ISO 13485, FDA quality system requirements, and applicable medical device regulations.
• Expertise in CAPA, nonconformance management, root cause analysis, auditing, inspection, calibration, and quality engineering.
• Experience leading quality functions in a contract manufacturing, custom manufacturing, or job shop environment.
• Ability to manage multiple customer requirements while maintaining consistent quality standards.
• Experience supporting or leading customer audits, regulatory inspections, or third-party certification audits.
• Strong leadership and communication skills, with the ability to collaborate across engineering, operations, and executive teams.

Occupational Code: 11-3051.01 — Quality Control Systems Managers.