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
In this role, 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.