Quality Assurance Manager

We are seeking a forward-thinking Quality Manager to lead Quality operations across our Americas Fulfillment Network. This role will drive the implementation and continuous improvement of a multi-site Quality Management System (QMS) within a regulated environment, partnering closely with Operations, Supply Chain, and Global Quality leadership.

Key Responsibilities

• Lead Quality across multiple fulfillment sites (Moreno Valley, Atlanta, Indianapolis)
• Drive compliance with ISO 13485 and global regulatory standards
• Partner cross-functionally with Operations, Transportation, Regulatory, and 3PL partners
• Own audits, CAPA, nonconformances, and investigations
• Deliver quality insights, risk assessments, and recommendations to leadership
• Lead continuous improvement, standardization, and QMS modernization (automation, digital tools, analytics)

Required Qualifications

• Bachelor’s degree in Engineering, Science, Operations, or related field
• 7+ years leading Quality in a multi-site, regulated environment
• Strong experience with ISO 13485 (or equivalent QMS)
• Hands-on leadership of CAPA, nonconformances, and structured problem solving (A3, 8D, DMAIC)
• Proven ability to lead audits and influence cross-functional stakeholders

Preferred Qualifications

• Medical device or pharmaceutical industry experience
• Lean / Six Sigma or continuous improvement background
• Experience with digital transformation, automation, or AI-driven quality tools