Plant Quality Director

LDI Search LTD.; Brookings (SD); On-site; USD 100,000 - 130,000; Full time

Job summary

A global healthcare innovator is seeking a Plant Quality Director to oversee quality operations in Brookings, SD. This high-impact leadership role involves setting the strategic direction for the Quality Management System and ensuring compliance with ISO 13485. The ideal candidate will have over 12 years of experience in a healthcare-regulated environment with significant leadership experience. Responsibilities include leading quality functions, driving operational excellence, and supporting continuous improvement initiatives.

Qualifications

• 12+ years of experience in quality within a healthcare-regulated industry.
• 8+ years of leadership experience managing quality teams.
• Experience as a Management Representative for ISO 13485 preferred.

Responsibilities

• Lead all site quality functions and strategy execution.
• Ensure full compliance with ISO 13485 and global medical device regulations.
• Champion continuous improvement in product reliability.

Skills

Leadership in quality management

Regulatory compliance (ISO 13485)

Process improvement

Root cause analysis

Change management

Team mentoring

Education

Bachelor's degree in science or engineering

Job description

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.