Systems Manager - Quality

Rockline Industries & Iatric Manufacturing • Sheboygan, WI

10h

About The Position

We’re seeking a Quality Systems/Sanitation Design Manager to lead and strengthen quality systems in an FDA‑regulated manufacturing environment. This role is ideal for a quality professional who pairs deep regulatory expertise with high emotional intelligence and the ability to build trusted relationships across all functions of the organization. Why This Role This is more than a compliance role — it’s an opportunity to shape quality culture through partnership, credibility, and leadership. You’ll play a critical role, supporting operations, and driving meaningful, sustainable improvement across the organization. Who We Are Rockline is a leading manufacturer operating in a highly regulated environment where quality, safety, and integrity are non‑negotiable . We are committed to delivering products that meet the highest regulatory and customer standards while fostering a workplace built on trust, collaboration, and accountability. Our culture is grounded in the Rockline values of Renew, Respect, Integrity, Teamwork, and Excellence . We believe strong quality systems are sustained not only through technical rigor, but through meaningful relationships, open communication, and shared ownership across all functions . At Rockline, we encourage thoughtful problem‑solving, respectful challenge, and continuous improvement—always doing what’s right for our people, our customers, and the consumers who rely on our products.

Requirements

• Bachelor’s degree in a scientific or engineering discipline (advanced degree preferred)
• 7+ years of experience with manufacturing quality systems
• 3+ years in a leadership or advisory role, with 5+ years of interaction with regulatory agencies
• Strong working knowledge of investigations, audits, change management, and regulated documentation systems
• High emotional intelligence , with a proven ability to influence, communicate effectively, and build strong cross‑functional relationships
• Ability to navigate difficult conversations and balance regulatory compliance with business needs

Responsibilities

• Lead and continuously improve FDA‑compliant quality systems
• Manage deviations, non‑conformances, investigations, and CAPA using a risk‑based, collaborative approach
• Own and oversee change management, document control, internal audits, customer complaints, and product release processes
• Partner closely with Manufacturing, Operations, Quality Assurance, and Leadership to ensure compliance is practical, effective, and sustainable
• Serve as a key leader during regulatory inspections and customer audits
• Coach and develop team members while fostering a culture of accountability, transparency, and continuous improvement

What This Job Offers

• Job Type: Full-time
• Career Level: Manager