Systems Manager - Quality

Rockline Industries & Iatric Manufacturing • Sheboygan, WI

1d

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.

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
• 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: Senior