Systems Manager Quality

Were seeking a Quality Systems/Sanitation Design Manager to lead and strengthen quality systems in an FDAâregulated 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 Youll Do

• Lead and continuously improve FDAâcompliant quality systems
• Manage deviations nonâconformances investigations and CAPA using a riskâbased 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

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

Why This Role

This is more than a compliance role its an opportunity to shape quality culture through partnership credibility and leadership. Youll 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 nonânegotiable. 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 problemâsolving respectful challenge and continuous improvementalways doing whats right for our people our customers and the consumers who rely on our products.

Required Experience:

Manager