Senior Manager, Quality & Compliance: QMS Leader

Infusystem,-Inc.-; Lenexa (KS); On-site; USD 120,000 - 150,000; Full time

Job summary

InfuSystem seeks a Senior Manager, Quality and Compliance to provide strategic leadership of the QMS, regulatory compliance program, licensing management, and accreditation activities across the organization.

You will drive audit programs, complaint management, supplier quality oversight, document control, licensing administration, and regulatory inspections, fostering a culture of quality and patient safety.

Qualifications

• Bachelor's degree in healthcare administration, regulatory affairs, quality management, life sciences, business, or related field.
• 5–7 years of progressive experience in healthcare quality, regulatory affairs, compliance, accreditation, or related disciplines.
• 3+ years of leadership or people management experience.
• ISO 13485 Lead Auditor certification preferred.

Responsibilities

• Lead and maintain the organization's Quality Management System (QMS) to ensure ISO 9001:2015 and ISO 13485:2016 requirements.
• Develop, implement, monitor, and continuously improve quality and compliance programs across all operational sites.
• Lead audits, inspections, and CAPA processes to ensure timely closure of findings.

Skills

Quality Management

Regulatory Compliance

Auditing

Leadership

Education

Bachelor's Degree in Healthcare Admin / Regulatory Affairs

Tools

eQMS

Power BI

Microsoft Excel

Job description

InfuSystem seeks a Senior Manager, Quality and Compliance to provide strategic leadership of the QMS, regulatory compliance program, licensing management, and accreditation activities across the organization.

You will drive audit programs, complaint management, supplier quality oversight, document control, licensing administration, and regulatory inspections, fostering a culture of quality and patient safety.