Plant Quality Director

Location: Onsite – Brookings, SD

Our client, a global healthcare innovator, is seeking an accomplished Plant Quality Director to lead quality operations at a key manufacturing site. This is a high‑impact leadership opportunity to shape quality strategy, strengthen compliance, and drive operational excellence within a regulated healthcare environment.

The Opportunity

You’ll serve as the site’s Quality Management Representative , setting the strategic direction for the Quality Management System (QMS) and fostering a culture of accountability, collaboration, and continuous improvement. You’ll lead a skilled team, partner cross‑functionally across operations, and play a pivotal role in ensuring products meet the highest standards of quality and regulatory compliance.

Key Focus Areas

• Lead all site quality functions and strategy execution.
• Ensure full compliance with ISO 13485 and global medical device regulations.
• Champion continuous improvement to reduce variation and enhance product reliability.
• Represent the site during audits, inspections, and regulatory interactions.
• Provide risk‑based leadership on quality and compliance decisions.
• Mentor and develop a high‑performing, quality‑driven team.

What You’ll Bring

• Bachelor’s degree (science or engineering discipline).
• 12+ years of experience in quality, regulatory, or manufacturing within a healthcare‑regulated industry.
• 8+ years of leadership experience, with proven success managing quality teams.
• Demonstrated expertise in audit readiness, root cause analysis, and process improvement.
• Experience serving as a Management Representative for ISO 13485 strongly preferred.
• Skilled at leading through change and influencing across complex, global environments.
• Valid driver’s license (occasional company vehicle use).

This is an exceptional opportunity for a quality leader ready to make a strategic impact in a growing, innovation‑driven organization at the forefront of healthcare advancement.