Senior Quality System Manager - NM - Rice Creek​/Fridley, MN; Onsite

Senior Quality Systems Manager

We anticipate the application window for this opening will close on 18 Jul 2026.

The Senior Quality Systems Manager provides strategic leadership for the Quality Management System (QMS), ensuring its effectiveness, regulatory compliance, and continuous improvement. This role is accountable for overseeing the Corrective and Preventive Action (CAPA) program and key quality system processes, including quality planning, management review, quality metrics, training, change control, and enterprise quality initiatives.

• Provide strategic and operational leadership for the QMS and continuous improvement initiatives.
• Lead the governance and oversight of the CAPA program, ensuring timely execution, effectiveness, and regulatory compliance.
• Oversee core quality system processes, including change control, training, management review, quality planning, and quality metrics.
• Monitor quality system performance, identify trends, and drive improvements through data‑driven decision making.
• Partner cross‑functionally to ensure quality system processes support business objectives while meeting applicable regulatory and quality requirements.
• Establish and maintain effective governance for quality system changes and enterprise quality initiatives.
• Support internal and external audits, regulatory inspections, and remediation activities as needed.
• Foster a culture of quality, accountability, and continuous improvement across the organization.

• Must Have (Minimum Requirements)
  
  • Bachelor’s degree required with a minimum of 7 years in Quality Systems within the medical device industry with 5+ years of people management experience.
  
  • OR advanced degree with a minimum of 5 years in Quality Systems within the medical device industry with 5+ years of people management experience.
• Nice to Have (Preferred Qualifications)
  
  • Strong understanding of global regulatory requirements for medical devices, including FDA Quality Management System Regulation (QMSR), ISO 13485, and European Medical Device Regulation.
  
  • Excellent written and verbal communication skills, with the ability to influence stakeholders and communicate effectively across all levels of the organization.
  
  • Demonstrated experience managing or leading CAPA processes in a regulated environment, including issue assessment, investigation, root cause analysis, action planning, implementation, and effectiveness verification.
  
  • Demonstrated leadership capability, including coaching others, driving cross‑functional collaboration, and fostering a culture of quality and continuous improvement.
  
  • Strong understanding of quality systems, including change control, nonconformance management, risk management, and management review.
  
  • Strong analytical and problem‑solving skills, with experience using structured methodologies to support fact‑based decision‑making.
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Location:

Rice Creek East/Fridley, MN (Onsite). Requires approximately 10% travel.