Systems Manager - Quality
Indexed description
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
- 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
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 improvement—always doing what’s right for our people, our customers, and the consumers who rely on our products.
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