SUMMARY:

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. Oversees 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.
o Ensure timely communication with affected stakeholders, customers, and regulatory agencies as required.
o 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.
o 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:
o Compliance Specialist(s)
o Quality Assurance Specialist(s)
o Product Complaint Analyst(s)
o 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:
o ISO 9001:2015
o ISO 13485:2016
o CMS Supplier Standards
o CHAP Accreditation Standards - or other Authorized Organization
o HIPAA Privacy and Security Regulations
o FDA Medical Device Regulations
o Health Canada Medical Device Requirements
o 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:
ο Certified Manager of Quality/Organizational Excellence (CMQ/OE)
ο 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
• Continuous Improvement Mindset
• Attention to Detail
• Organizational Agility
• Team Leadership and Development
Travel Requirements
• Ability to travel up to 15% to support direct reports, audits, inspections, supplier
assessments, accreditation activities, and company meetings.
Personal & Professional Attributes
• Strong work ethic and accountability
• Sound judgment and integrity
• Excellent verbal and written communication skills
• Intellectual curiosity and commitment to learning
• Data-driven decision-making skills
• Courage to challenge the status quo and lead change
• Passion for quality, compliance, patient safety, and customer service
• Collaborative and team-oriented leadership style
• Commitment to continuous improvement and operational excellence

This structure elevates both positions into a true senior management role with
responsibility for the entire Quality & Compliance function while eliminating duplicated
duties and creating a clearer succession path beneath the VP/Sr. Director level.

COMPREHENSIVE BENEFIT PACKAGE:

At InfuSystem, we give our employees the tools to succeed both on and off the job. Our generous benefits package provides comprehensive coverage to help you protect your health and earning power and prepare for the future. In addition, we offer perks and programs that help you grow in your career and make InfuSystem a great place to work!

• Health plan options that include an employer contribution
• Health Savings Account (HSA)
• Healthcare and Dependent Care Flexible Spending Accounts (FSA)
• Dental and Vision premiums covered by InfuSystem
• Life Insurance, STD & LTD
• Paid Parental Leave
• Adoption and Fertility Assistance
• 401(k) with a specified Company Match
• Employee Stock Purchase Program
• Tuition Assistance
• Generous Paid Time Off plan
• Employee Assistance Program
• Competitive Pay
• Employee Referral Bonus