Sr. Manager, Quality & Compliance

Senior Manager, Quality and Compliance

InfuSystem 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, InfuSystem improves clinician access to quality medical equipment and promotes patient wellness and safety while reducing the overall cost of infusion care.

InfuSystem 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. InfuSystem 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, InfuSystem 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.

Essential Duties and Responsibilities:

• Quality Management & Regulatory Oversight
• 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.
• Compliance, Accreditation & Licensing
• Ensure ongoing compliance with CMS Supplier Standards, CHAP accreditation requirements, HIPAA Privacy and Security regulations, and other applicable federal, state, provincial, and local regulations.
• Monitor regulatory changes and assess organizational impact and implementation requirements.
• Research licensing, accreditation, and regulatory requirements for new products, services, and business initiatives.
• Oversee maintenance and renewal of all business licenses, including state, sales tax, and other applicable state and federal licenses.
• Serve as a subject matter expert and advisor on healthcare compliance and accreditation matters.
• Audit & Inspection Management
• Manage internal audit programs and external auditing activities. Oversee annual audit schedules and ensure timely completion of audits and corrective actions.
• Lead customer audits, FDA inspections, Health Canada inspections, accreditation surveys, Board of Pharmacy inspections, and other regulatory reviews.
• Verify effectiveness of corrective actions and ensure closure of audit findings within established timelines.
• Complaint Management & Incident Investigations
• Oversee quality and patient complaint programs to ensure timely documentation, investigation, reporting, and resolution of product related complaints and patient reported complaints.
• Ensure compliance with FDA, Health Canada, and other reporting requirements.
• Investigate compliance incidents, privacy concerns, and potential regulatory violations.
• Conduct compliance risk assessments, document findings, identify trends, and recommend corrective actions.
• Provide leadership reporting on complaint and compliance trends and organizational risks.
• Supplier Quality & Recall Management
• Manage supplier quality performance monitoring and support supplier evaluation programs.
• Conduct or coordinate supplier audits and corrective action activities.
• Oversee product recall, correction, and field action activities.
• Ensure timely communication with affected stakeholders, customers, and regulatory agencies as required.
• Ensure accurate records and documentation associated with recalls and remediation efforts.
• Document Control & Training
• Oversee document control systems for quality system and compliance documentation, policies, procedures, forms, work instructions, and manuals.
• Ensure controlled documents remain current, accurate, and compliant with applicable standards.
• Deliver training as needed and ensure team members maintain required certifications and training compliance.
• Leadership Responsibilities
• Provide leadership, coaching, and performance management to Quality and Compliance personnel.
• Oversee: Compliance Specialist(s), Quality Assurance Specialist(s), Product Complaint Analyst(s), Quality Control Supervisor and QC personnel
• Foster a culture of accountability, continuous improvement, and regulatory excellence.
• Manage departmental budgets and resource planning.
• Collaborate effectively with Operations, Clinical Services, Biomed, Human Resources, Legal, Payor Contracting, and Executive Leadership teams.

Required 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, ISO 13485:2016, CMS Supplier Standards, CHAP Accreditation Standards or other Authorized Organization, HIPAA Privacy and Security Regulations, FDA Medical Device Regulations, Health Canada Medical Device Requirements, Healthcare licensing and regulatory requirements.
• Certified ISO 13485 Lead Auditor required.
• Experience leading regulatory inspections and accreditation surveys preferred.
• Lean, Six Sigma Green Belt, Black Belt, or other continuous improvement certification preferred.
• Knowledge of medical device complaint handling, vigilance reporting, product recalls, and corrective and preventive action (CAPA) processes.

Preferred Qualifications:

• Master's degree in Healthcare Administration, Quality Management, Regulatory Affairs, Business Administration, Public Health, Life Sciences, or a related field.
• Quality certification such as: Certified Manager of Quality/Organizational Excellence (CMQ/OE), Certified Quality Auditor (CQA).
• Certification in Healthcare Compliance (CHC) or equivalent compliance credential.
• Certified in Healthcare Privacy Compliance (CHPC) or demonstrated expertise in HIPAA Privacy and Security programs.
• Experience managing both ISO-certified quality systems and healthcare compliance/accreditation programs within a medical device, infusion therapy, durable medical equipment (DME) or healthcare services organization.
• Experience leading FDA inspections, Health Canada inspections, CHAP accreditation surveys, Board of Pharmacy inspections, and customer audits.
• Experience with enterprise quality management systems (eQMS) and electronic document control platforms.
• Demonstrated success leading multi-site quality and compliance organizations during periods of growth and organizational change.
• Advanced proficiency with data analysis, dashboard development, KPI reporting, and Microsoft Office applications, particularly Excel, Power BI, and Word.

Competencies:

• Strategic Leadership
• Regulatory and Compliance Expertise
• Quality Systems Management
• Audit Management
• Root Cause Analysis and Problem Solving
• Risk Assessment and Mitigation
• Influencing and Relationship Building
• Project Management
• Analytical Thinking
• Effective Communication