Sr. Manager, Quality & 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 companys 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.

SUMMARY:

The Senior Manager Quality and Compliance provides strategic and operational leadership for the organizations 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 organizations 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
Bachelors 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
Masters 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 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

Required Experience:

Manager