Sr. Manager, Quality & Compliance

Infu System is a leading national health care service provider, facilitating outpatient care for durable medical equipment manufacturers and health care providers by delivering ambulatory pumps and supplies, along with related clinical, biomedical and billing services, to practices and patients nationwide. With a comprehensive suite of services, Infu System improves clinician access to quality medical equipment and promotes patient wellness and safety while reducing the overall cost of infusion care.

Infu System offers Oncology, Pain Management and Wound Care therapies, including Negative Pressure Wound Therapy. The company’s Durable Medical Equipment (DME) Services are composed of direct payer rentals, pump and consumable sales, and biomedical services and repair, including on‑site and depot services. Infu System provides the sale, rental, lease and associated supplies, including infusion pumps, nerve blocks for acute pain, nerve block catheters, postoperative pain pumps, central venous catheters, IV pumps, pole‑mounted pumps, syringe pumps, enteral pumps, Huber needles, clean room supplies, IV extension tubing, pump tubing, ambulatory pumps, replacement pumps, disposable products, central venous access devices, closed system transfer devices, negative pressure wound therapy vacs, wound vac, and chemotherapy and oncology infusion pumps.

Biomedical services include both on‑site and depot preventive maintenance, repair and warranty services, ranging from equipment inspections to extensive repairs, including compression device systems, defibrillators, EKG machines, electrosurgical units, external pacemakers, humidifiers, infusion pumps, LCDs, light sources, modules, patient monitors, printers, pulse oximeters, telemetry transmitters and tourniquets – all completed to factory specifications.

Headquartered in Rochester Hills, Michigan, Infu System delivers local, field‑based customer support and operates Centers of Excellence in Michigan, Kansas, California, Massachusetts, Texas and Ontario, Canada.

The Senior Manager, Quality and Compliance provides strategic and operational leadership for the organization's Quality Management System (QMS), healthcare compliance program, accreditation activities, licensing management, and regulatory compliance initiatives. This role ensures compliance with applicable quality standards, healthcare regulations, accreditation requirements, and internal policies while driving continuous improvement across the organization.
The Senior Manager leads audit programs, complaint management, supplier quality oversight, document control, licensing administration, regulatory inspections, quality improvement initiatives, and compliance investigations. This position partners closely with leaders throughout the organization to promote a culture of quality, accountability, regulatory excellence, and patient safety.

• Lead and maintain the organization's Quality Management System (QMS) to ensure compliance with ISO 9001:2015 and ISO 13485:2016 requirements.
• Develop, implement, monitor, and continuously improve quality and compliance programs across all operational sites.
• Facilitate Quarterly Quality and Performance Improvement Reviews and monitor completion of associated action items.
• Conduct trend analysis and performance reporting to identify opportunities for organizational improvement.
• Lead root cause investigations and corrective/preventive action initiatives to ensure sustainable resolution of quality and compliance issues.
• Partner with operational leaders to drive continuous improvement and regulatory readiness.

• Ensure ongoing compliance with CMS…