Supervisor, Quality Compliance

Cardinal Health•El Paso, TX

5d•$70,400 - $90,450

About The Position

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.

Requirements

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

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