Systems Manager - Quality

Systems Manager - Quality

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.

What You'll Do

• 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 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 cross-functional 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 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 improvementalways doing what's right for our people, our customers, and the consumers who rely on our products.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.