Supervisor, Quality Compliance

Quality Systems Manager

Quality Systems ensures the integrity, compliance, and continuous improvement of Cardinal Health's Quality Management System (QMS) across manufacturing and distribution operations. This function plays a critical role in maintaining product quality, patient safety, and regulatory compliance by managing core quality processes such as CAPA, nonconformance handling, change control, document control, and audit readiness.

Quality Systems partners cross-functionally with Operations, Regulatory Affairs, and Supply Chain to ensure all products meet applicable regulatory requirements (FDA, ISO, MDSAP) and are released in a timely and compliant manner. Additionally, the function drives continuous improvement initiatives, supports regulatory inspections, and ensures effective responses to internal and external audit observations.

Responsibilities

• Leads and maintains the site Quality Management System (QMS) to ensure compliance with FDA (21 CFR Part 820), ISO 13485, and other applicable regulations
• Manages CAPA processes, including investigations, root cause analysis, corrective actions, and effectiveness checks
• Oversees Nonconformance Reports (NCRs), ensuring proper documentation, investigation, and timely resolution
• Ensures effective execution of Change Control and Document Control processes
• Oversees product release activities and ensures compliance prior to distribution
• Manages product holds, including investigations and coordination of product detentions in Distribution Centers (DCs)
• Serves as a key contact during regulatory inspections, including FDA interactions and product reviews
• Leads and supports internal, external, and customer audits, ensuring audit readiness and timely closure of findings
• Ensures compliance with training requirements and monitors training effectiveness for regulated activities
• Oversees calibration programs and supports environmental and process control requirements
• Coordinates and supports customer technical visits and quality-related inquiries
• Supervises, coaches, and develops Quality Technicians, ensuring team performance and engagement
• Drives continuous improvement initiatives using quality data, metrics, and trend analysis
• Supports Management Review processes and execution of related action plans

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field preferred
• 3–5+ years of experience in the medical device industry, with strong focus on Quality Systems, preferred
• Minimum 2 years of leadership or supervisory experience, preferred
• Strong knowledge of FDA regulations (21 CFR Part 820), ISO 13485, and MDSAP, preferred
• Experience with CAPA, NCRs, Change Control, audits, and product release processes, preferred
• Experience in sterile and/or non-sterile manufacturing environments preferred
• Strong root cause analysis and problem-solving skills, preferred
• Ability to work cross-functionally and communicate effectively with internal and external stakeholders, preferred
• Proficiency in Microsoft Office applications, preferred
• Advanced English communication skills (written and verbal) and Spanish (advanced), preferred

What is expected of you and others at this level

• Applies working knowledge of quality systems and regulatory requirements to manage day-to-day operations and solve moderately complex problems
• Leads a small team, providing direction, coaching, and performance feedback to ensure alignment with organizational goals
• Exercises judgment within defined procedures and practices to determine appropriate actions
• Collaborates cross-functionally to ensure quality and compliance objectives are met
• Supports and drives continuous improvement initiatives within the quality system
• Ensures adherence to policies, procedures, and regulatory requirements, escalating issues as needed
• Communicates effectively with internal teams and external stakeholders, including auditors and customers
• Demonstrates accountability, attention to detail, and a strong compliance mindset Contributes to building a positive, quality-focused culture within the organization

Anticipated salary range: $70,400 - $90,450

Bonus eligible:
No

Benefits:
Cardinal Health offers a wide variety of benefits and…