Quality Assurance Manager

Cardinal Health•El Paso, TX

12d•$91,400 - $130,600•Onsite

About The Position

Quality Management defines, implements, and sustains quality systems, policies, and processes that are critical to regulatory compliance, product integrity, and patient safety within a regulated medical device manufacturing environment. It provides strategic leadership to drive quality excellence, ensure compliance with global regulations, and foster a strong culture of accountability, engagement, and continuous improvement across the organization.

Requirements

10+ years of experience in Quality within the medical device industry preferred
Bachelor’s degree in Engineering or related field, preferred or equivalent work experience
Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and MDSAP, preferred
Proven experience leading regulatory inspections and audits (FDA, ISO, MDSAP), preferred
Experience with sterile products and external sterilization processes preferred
Strong analytical skills with demonstrated ability to drive data-based, risk-informed decisions
Proven leadership in team development, cultural transformation, and employee engagement
Excellent communication skills with ability to influence across all organizational levels and external stakeholders

Responsibilities

Own and lead the development, implementation, and continuous improvement of the site Quality Management System, ensuring compliance with FDA 21 CFR Part 820, ISO 13485, and MDSAP requirements.
Provide strategic leadership and direction to the Quality function, aligning quality objectives with business goals while maintaining the highest standards of compliance, product quality, and patient safety.
Oversee quality assurance activities for sterile and non-sterile products, including control, release, and oversight of sterile product received from external sterilization providers, ensuring integrity, traceability, and compliance throughout distribution.
Lead and make risk-based decisions impacting product quality, including the establishment and management of QA holds driven by customer complaints, internal quality signals, or business needs.
Lead and represent the site during regulatory inspections and audits, including FDA, MDSAP, ISO, and customer audits, ensuring effective preparation, execution, and timely closure of observations.
Drive robust complaint handling and investigation processes, ensuring timely containment, thorough root cause analysis, and effective corrective and preventive actions (CAPA).
Actively monitor, analyze, and drive improvements based on quality data and KPIs, identifying trends, mitigating risks, and supporting product release decisions.
Lead Site Quality Management Reviews, effectively communicating performance metrics, risks, and improvement plans to senior leadership.
Lead, coach, and develop a high-performing Quality organization, fostering a positive, accountable, and engaging work environment, recognizing that strong culture and employee engagement are critical to compliance and operational success.
Promote a strong culture of quality, compliance discipline, and contamination control awareness across all levels of the organization through clear, consistent, and effective communication.