Cardinal Health · 1 day ago
Site Quality Manager
Jacksonville, TX
Full-time
Onsite
Senior Level, Lead/Staff
$91K/yr - $131K/yr
8+ years expCardinal Health is a leading company in the healthcare sector, and they are seeking a Site Quality Manager to provide strategic oversight for the Quality function. The role involves managing quality staff, driving regulatory compliance, and ensuring product quality and patient safety throughout the product lifecycle through collaboration and risk management.
HealthcareHospitalHealth CareMedical
Responsibilities
Lead and develop the Quality function, providing strategic oversight, direction, and mentorship to direct reports and site personnel to achieve quality goals and ensure regulatory compliance
Drive the continuous improvement of the Quality Management System (QMS) by developing, implementing, and maintaining quality policies, procedures, and processes in adherence to ISO 13485, FDA QSR, and other relevant standards
Oversee critical quality systems, including document control, CAPA, NCR, and complaint handling within a manufacturing environment
Direct and facilitate all audit activities, including regulatory (e.g., FDA, MDSAP), customer, and corporate audits, ensuring audit readiness and timely, effective responses to findings
Conduct Site Quality Management Reviews and analyze key performance indicator (KPI) metrics to identify trends, escalate issues to senior management, and inform critical decisions impacting product release and patient safety
Champion risk management initiatives, including hazard analysis and FMEA, and lead root cause analysis and problem-solving efforts for quality issues
Collaborate cross-functionally with engineering, production, and supply chain teams to ensure robust product quality and process compliance across the entire product lifecycle, from design control and supplier qualification to manufacturing and post-market surveillance
Qualification
Required
Previous quality experience in a medical device manufacturing setting required
In-depth knowledge and practical application of ISO 13485, FDA 21 CFR Part 820 (QSR), and other relevant international quality standards and regulations
Extensive experience with regulatory audits (e.g., FDA, MDSAP, ISO) and responding to findings
Strong understanding and experience with key quality processes: CAPA, Non-Conformance, Complaint Handling, Document Control, and Change Control
Experience with all phases of the product lifecycle, including design control, supplier quality, manufacturing quality, and post-market surveillance
Previous experience managing and developing both hourly and salaried professionals
Preferred
Bachelor's degree in related field preferred
ASQ CQE, CQA, or CMQ/OE certifications preferred
8+ years of quality experience preferred
Experience with injection molding processes preferred
Benefits
Medical, dental and vision coverage
Paid time off plan
Health savings account (HSA)
401k savings plan
Access to wages before pay day with myFlexPay
Flexible spending accounts (FSAs)
Short- and long-term disability coverage
Work-Life resources
Paid parental leave
Healthy lifestyle programs
Company
Cardinal Health
Cardinal Health is a manufacturer and distributor of medical and laboratory products.
10001+ employees
H1B Sponsorship
Cardinal Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (128)
2024 (116)
2023 (140)
2022 (158)
2021 (106)
2020 (142)
Funding
Current Stage
Public CompanyTotal Funding
$1.08B2025-08-28Post Ipo Debt· $1B
2006-08-16Post Ipo Debt· $78M
1983-08-12IPO
Leadership Team
Aaron Alt
Chief Financial Officer
T
Tony Caprio
Executive Vice President
Recent News
Digital Commerce 360
2026-02-07
2026-02-06
WSJ.com: US Business
2026-02-06
Company data provided by crunchbase