Senior Quality Manager

EWI is the leader in materials sciences and the go to experts that many of the country’s largest and most innovative organizations call to assist with their most difficult assignments. Our business success relies on strong execution and continuous improvement – driven by the expertise and teamwork of our employees. We are always searching for exceptional candidates to join the EWI team and be a part of our forward-thinking, innovative, best-in-class organization! We have a rich history in the community and are and are proud to call Columbus our home.

We are seeking a highly experienced and strategic Senior Quality Manager to build and lead our quality function from the ground up. This is a senior leadership role responsible for establishing a robust Quality Management System (QMS) and driving a culture of quality, compliance, and continuous improvement across the organization. The ideal candidate brings deep expertise in regulated environments and a strong background in contract research.

ESSENTIAL FUNCTIONS:

• Establish and lead the QMS: Design, implement, and institutionalize a comprehensive Quality Management System from the ground up, ensuring alignment with relevant regulatory standards and business objectives
• Define and own all quality policies, procedures, work instructions, and standards across manufacturing and engineering operations
• Serve as the organization’s senior quality authority, providing strategic direction and guidance to executive leadership on all quality-related matters
• Lead all internal and external audits, including regulatory inspections, and ensure timely and effective resolution of findings
• Oversee root cause analysis (RCA) and corrective/preventive action (CAPA) processes across the organization
• Build, mentor, and scale a high-performing quality team, including quality engineers, auditors, and inspectors
• Partner with contract research organizations (CROs) and external partners to ensure quality standards are met throughout outsourced activities
• Manage supplier and vendor quality programs, including qualification, audits, and ongoing performance oversight
• Drive continuous improvement initiatives using methodologies such as Lean, Six Sigma, or 8D
• Represent the quality function in client-facing interactions, regulatory submissions, and contract negotiations
• Monitor and report on quality KPIs, trends, and risks to the executive team and board as required