Site Quality Manager

Cardinal Health • Deland, FL

5d

About The Position

This leadership role provides strategic oversight for the Quality function, driving regulatory compliance (ISO 13485, FDA QSR) and continuous improvement of the Quality Management System. Responsibilities include managing quality staff, developing policies, overseeing critical quality processes like CAPA and document control, leading audit readiness, and ensuring product quality and patient safety throughout the entire product lifecycle through cross-functional collaboration and risk management.

Requirements

• Bachelor’s degree in related field preferred
• 8+ years of quality experience preferred
• Previous quality experience in a medical device manufacturing setting required
• Experience with injection molding processes preferred
• 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

Nice To Haves

• ASQ CQE, CQA, or CMQ/OE certifications preferred

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.

Benefits

• Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager