Systems Manager - Quality

We're seeking a Quality Systems/Sanitation Design Manager to lead and strengthen quality systems in an FDAregulated 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.

What You'll Do

• Lead and continuously improve FDAcompliant quality systems
• Manage deviations, nonconformances, investigations, and CAPA using a riskbased, 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 You Bring

• 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 crossfunctional relationships
• Ability to navigate difficult conversations and balance regulatory compliance with business needs

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 nonnegotiable . 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 problemsolving, respectful challenge, and continuous improvement-always doing what's right for our people, our customers, and the consumers who rely on our products.