Senior Quality & Compliance Leader (ISO & Audits)

InfuSystem; Lenexa (KS); On-site; USD 140,000 - 195,000; Full time

Benefits offered by this job

Health plan options with employer-con‑

Health Savings Account

Dental and Vision premiums

Life Insurance

Paid Parental Leave

401(k) with Company Match

Employee Stock Purchase Program

Tuition Assistance

Generous Paid Time Off

Employee Assistance Program

Competitive Pay

Job summary

InfuSystem is seeking a Senior Manager, Quality and Compliance to provide strategic and operational leadership for the organization's QMS, accreditation, licensing, and regulatory initiatives. You will drive continuous improvement and ensure patient safety across nationwide services.

The role leads audits, complaint management, supplier quality oversight, document control, and regulatory inspections while collaborating with executives to foster a culture of quality and accountability.

Qualifications

• Bachelor's Degree in Healthcare Administration, Regulatory Affairs, Quality Management, Life Sciences, Business Administration, or related field.
• Minimum 5-7 years of progressive experience in healthcare quality, regulatory affairs, compliance, accreditation, or related disciplines.
• Minimum 3 years of leadership or people management experience.
• Strong working knowledge of ISO 9001:2015 and ISO 13485:2016.
• CMS Supplier Standards, CHAP Accreditation Standards, HIPAA Privacy and Security Regulations.
• FDA Medical Device Regulations and Health Canada Medical Device Requirements.

Responsibilities

• Lead and maintain the organization’s Quality Management System (QMS) to ensure compliance with ISO standards.
• Develop, implement, monitor, and continuously improve quality and compliance programs across all sites.
• Facilitate Quality and Performance Improvement Reviews and monitor action items.
• Conduct trend analysis and performance reporting to identify improvement opportunities.
• Lead root cause investigations and CAPA initiatives for sustainable resolution.
• Partner with leaders to drive continuous improvement and regulatory readiness.
• Oversee internal audits and external inspections, including FDA and Health Canada reviews.
• Manage complaint programs and regulatory reporting obligations.

Skills

Strategic Leadership

Regulatory and Compliance Expertise

Quality Systems Management

Audit Management

Root Cause Analysis

Risk Assessment

Influencing and Relationship Building

Project Management

Analytical Thinking

Effective Communication

Education

Bachelor's Degree in Healthcare Administration

Master's degree in related field (preferred)

Tools

Excel

Power BI

Word

Job description

InfuSystem is seeking a Senior Manager, Quality and Compliance to provide strategic and operational leadership for the organization's QMS, accreditation, licensing, and regulatory initiatives. You will drive continuous improvement and ensure patient safety across nationwide services.

The role leads audits, complaint management, supplier quality oversight, document control, and regulatory inspections while collaborating with executives to foster a culture of quality and accountability.