Senior Manager, Quality & Compliance Excellence

InfuSystem, Inc.; Lenexa, Northern (KS, KY); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health plan options

HSA

Dental & Vision

Job summary

InfuSystem, Inc. seeks a Senior Manager, Quality and Compliance to lead the organization's QMS, regulatory program, accreditation efforts, licensing management, and continuous improvement across sites.

You will oversee audits, CAPA, supplier quality, complaints, and incident investigations, ensuring patient safety and regulatory readiness. You will collaborate with Operations, Biomed, Legal, and Leadership to advance quality practices, manage budgets, and mentor a team of QA specialists,

Qualifications

• Bachelor's degree in a healthcare or regulatory field is required.
• Minimum 5–7 years in healthcare quality, regulatory affairs, or compliance roles.
• 3+ years of leadership or people management experience.
• Strong knowledge of ISO 9001:2015, ISO 13485:2016, CMS supplier standards, HIPAA, FDA/Health Canada regulations.

Responsibilities

• Lead the Quality Management System (QMS) to ensure ISO 9001:2015 and ISO 13485:2016 compliance.
• Develop and monitor comprehensive quality and compliance programs across operational sites.
• Oversee audits, inspections, corrective actions, and CAPA processes.
• Manage complaint programs and incident investigations with regulatory reporting.
• Direct supplier quality oversight and recall management across multiple sites.
• Oversee document control systems and training to maintain compliance.

Skills

Regulatory compliance

Quality management

ISO 9001/13485

Audit leadership

CAPA & investigations

HIPAA Privacy

Leadership

Cross-functional collaboration

Education

Bachelor's degree in Healthcare Administration, Regulatory Affairs, Life Sciences

Tools

eQMS

Microsoft Office (Excel, Power BI)

Job description

InfuSystem, Inc. seeks a Senior Manager, Quality and Compliance to lead the organization's QMS, regulatory program, accreditation efforts, licensing management, and continuous improvement across sites.

You will oversee audits, CAPA, supplier quality, complaints, and incident investigations, ensuring patient safety and regulatory readiness. You will collaborate with Operations, Biomed, Legal, and Leadership to advance quality practices, manage budgets, and mentor a team of QA specialists,