Systems Manager - Quality

About the role

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.

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

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

Qualifications

• 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

Skills

• Comprehensive understanding of FDA regulations and guidelines
• Strategic thinking and problem-solving skills
• Excellent interpersonal and communication skills
• Strong organizational and project management skills

Benefits

• Competitive compensation package
• Flexible work schedule
• Professional development opportunities
• Health and wellness programs
• Employee recognition and rewards

Pay

Competitive salary commensurate with experience

Schedule

Full-time position

Rockline

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.