Senior Manager, Quality & Compliance

Jobtailor; Lenexa (KS); On-site; USD 110,000 - 150,000; Full time

Job summary

Jobtailor in Lenexa, KS is seeking a senior Quality & Compliance leader to own the QMS for ISO 9001:2015 and ISO 13485:2016, drive cross-site quality programs, and lead internal and external audits. The role requires extensive regulatory knowledge across CMS, CHAP, HIPAA, FDA, and Health Canada, with hands-on CAPA and quality improvement ownership.

We value leadership, strategic thinking, and collaboration with Operations, Clinical Services, and Legal teams to maintain regulatory readiness and

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
• Strong working knowledge of ISO 13485:2016
• Strong working knowledge of CMS Supplier Standards
• Strong working knowledge of CHAP Accreditation Standards or other Authorized Organization
• Strong working knowledge of HIPAA Privacy and Security Regulations
• Strong working knowledge of FDA Medical Device Regulations
• Strong working knowledge of Health Canada Medical Device Requirements
• Certified ISO 13485 Lead Auditor required
• Ability to travel up to 15%
• Master's degree and additional quality, healthcare compliance, privacy, and auditing certifications preferred
• Experience leading regulatory inspections and accreditation surveys preferred
• Experience managing ISO-certified quality systems and healthcare compliance/accreditation programs preferred

Responsibilities

• Lead and maintain the QMS for ISO 9001:2015 and ISO 13485:2016 compliance
• Develop, implement, monitor, and improve quality and compliance programs across sites
• Facilitate Quarterly Quality and Performance Improvement Reviews and track action items
• Conduct trend analysis and performance reporting
• Lead root cause investigations and CAPA initiatives
• Partner with leaders on continuous improvement and regulatory readiness
• Ensure compliance with CMS Supplier Standards, CHAP, HIPAA, and applicable regs
• Monitor regulatory changes and assess impact
• Research licensing, accreditation, and regulatory requirements for new products
• Oversee maintenance and renewal of business licenses
• Advise on healthcare compliance and accreditation matters
• Manage internal audit programs and external auditing activities
• Lead customer audits, FDA and Health Canada inspections and accreditation surveys
• Verify corrective-action effectiveness and close audit findings on time
• Oversee quality and patient complaint programs from documentation to resolution
• Investigate compliance incidents and privacy concerns
• Conduct compliance risk assessments and recommend actions
• Manage supplier quality monitoring and supplier evaluations
• Coordinate supplier audits and corrective actions
• Oversee recalls, corrections, and field actions
• Maintain recall/remediation records and communicate with stakeholders
• Oversee document control systems for quality and compliance docs
• Deliver training and ensure certification and training compliance
• Provide leadership and performance management to Quality and Compliance personnel
• Manage departmental budgets and resource planning
• Collaborate with Operations, Clinical Services, Biomed, HR, Legal, Payor Contracting, and Exec Leadership

Skills

Quality Management

Regulatory Compliance

Root Cause Analysis

CAPA

Data Analysis

Leadership

Communication

Education

Bachelor's degree in Healthcare Administration

Master's degree preferred

Tools

eQMS

Electronic Document Control

Excel

Power BI

Word

Job description

• Lead and maintain the organization's Quality Management System (QMS) for ISO 9001:2015 and ISO 13485:2016 compliance
• Develop, implement, monitor, and continuously improve quality and compliance programs across operational sites
• Facilitate Quarterly Quality and Performance Improvement Reviews and monitor action items
• Conduct trend analysis and performance reporting
• Lead root cause investigations and corrective/preventive action initiatives
• Partner with operational leaders on continuous improvement and regulatory readiness
• Ensure compliance with CMS Supplier Standards, CHAP accreditation requirements, HIPAA, and applicable regulations
• Monitor regulatory changes and assess organizational impact
• Research licensing, accreditation, and regulatory requirements for new products, services, and initiatives
• Oversee maintenance and renewal of business licenses
• Advise on healthcare compliance and accreditation matters
• Manage internal audit programs and external auditing activities
• Lead customer audits, FDA inspections, Health Canada inspections, accreditation surveys, Board of Pharmacy inspections, and other regulatory reviews
• Verify corrective-action effectiveness and close audit findings within established timelines
• Oversee quality and patient complaint programs, including documentation, investigation, reporting, and resolution
• Investigate compliance incidents, privacy concerns, and potential regulatory violations
• Conduct compliance risk assessments and recommend corrective actions
• Manage supplier quality performance monitoring and supplier evaluation programs
• Coordinate supplier audits and corrective actions
• Oversee product recalls, corrections, and field actions
• Maintain accurate recall and remediation records and communicate with stakeholders and regulatory agencies
• Oversee document control systems for quality and compliance documentation
• Deliver training and ensure certification and training compliance
• Provide leadership, coaching, and performance management to Quality and Compliance personnel
• Manage departmental budgets and resource planning
• Collaborate with Operations, Clinical Services, Biomed, Human Resources, Legal, Payor Contracting, and Executive Leadership teams

Requirements

• 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
• Strong working knowledge of ISO 13485:2016
• Strong working knowledge of CMS Supplier Standards
• Strong working knowledge of CHAP Accreditation Standards – or other Authorized Organization
• Strong working knowledge of HIPAA Privacy and Security Regulations
• Strong working knowledge of FDA Medical Device Regulations
• Strong working knowledge of Health Canada Medical Device Requirements
• Strong working knowledge of healthcare licensing and regulatory requirements
• Certified ISO 13485 Lead Auditor required
• Knowledge of medical device complaint handling, vigilance reporting, product recalls, and corrective and preventive action (CAPA) processes
• Ability to travel up to 15%
• Master's degree and additional quality, healthcare compliance, privacy, and auditing certifications preferred
• Experience leading regulatory inspections and accreditation surveys preferred
• Experience managing ISO-certified quality systems and healthcare compliance/accreditation programs preferred
• Experience with enterprise quality management systems (eQMS) and electronic document control platforms preferred
• Advanced proficiency with data analysis, dashboard development, KPI reporting, and Microsoft Office applications, particularly Excel, Power BI, and Word preferred

Core Competencies

Demonstrates expertise in leading Quality Management Systems (QMS) for ISO 9001:2015 and ISO 13485:2016 compliance, with a strong focus on healthcare regulatory standards, quality improvement initiatives, and effective leadership in compliance and accreditation processes.

Highest-signal resume keywords

• ISO 9001:2015 Compliance
• ISO 13485:2016 Compliance
• CMS Supplier Standards
• Certified ISO 13485 Lead Auditor
• Healthcare Regulatory Affairs

Hard Skills

• Quality Management System (QMS)
• Regulatory Compliance
• Root Cause Analysis
• Corrective and Preventive Action (CAPA)
• Data Analysis
• Trend Analysis
• Performance Reporting
• Audit Management
• Accreditation Standards
• Healthcare Licensing

Soft Skills

• Leadership
• Coaching
• Collaboration
• Performance Management
• Communication

Certifications & Qualifications

• Certified ISO 13485 Lead Auditor
• Additional Quality Certifications
• Healthcare Compliance Certifications

Industry Keywords

• ISO Standards
• HIPAA Regulations
• FDA Medical Device Regulations
• Health Canada Medical Device Requirements
• CHAP Accreditation Standards

Tools & Technologies

• Enterprise Quality Management Systems (eQMS)
• Electronic Document Control Platforms
• Microsoft Excel
• Microsoft Power BI
• Microsoft Word