Cardinal Health

Quality Assurance Manager

Cardinal Health • $91K — $130K *
El Paso, TX 79936In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • 10+ years of experience in Quality within the medical device industry preferred
  • Bachelor's degree in Engineering or related field, or equivalent experience
  • Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and MDSAP
  • Experience leading regulatory inspections and audits (FDA, ISO, MDSAP)
  • Familiarity with sterile products and external sterilization processes
  • Strong analytical skills for data-driven decision making
  • Proven leadership ability in team development and employee engagement

Responsibilities

  • Own and enhance the site's Quality Management System for FDA and ISO compliance
  • Provide strategic leadership aligning quality objectives with business goals
  • Oversee quality assurance activities for sterile and non-sterile products
  • Lead risk-based decisions impacting product quality and QA hold management
  • Represent the site during regulatory inspections and audits ensuring compliance
  • Drive complaint handling processes including root cause analysis and CAPA
  • Monitor quality data to improve performance and support product release

Benefits

  • Medical, dental and vision coverage
  • Paid time off plan
  • Health savings account (HSA)
  • 401k savings plan
  • Access to wages before payday
  • Flexible spending accounts (FSAs)
  • Short- and long-term disability coverage
  • Work-Life resources
  • Paid parental leave
  • Healthy lifestyle programs
Full Job Description
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.


Qualifications
  • 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


What is expected of you and others at this level
  • Leads the Quality function at the site level, managing department operations and providing direction to professional employees, supervisors, and support staff.
  • Drives the development and execution of quality strategies, policies, and procedures aligned with organizational goals and regulatory requirements.
  • Ensures teams operate within established guidelines while fostering accountability, engagement, and continuous improvement.
  • Makes decisions with significant impact on product quality, regulatory compliance, and business performance, applying a risk-based approach that prioritizes patient safety and customer requirements.
  • Interacts with internal and external stakeholders, including senior leadership, regulatory agencies, and customers, to resolve complex issues and align on quality-related matters.
  • Influences cross-functional teams and builds consensus across multiple stakeholders to achieve quality and business objectives.


Anticipated salary range: $91,400 - $130,600

Bonus eligible: Yes

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


Application window anticipated to close: 7/17/2025 *if interested in opportunity, please submit application as soon as possible.

The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

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About Cardinal Health

Cordis Corporation, a Johnson & Johnson company, has pioneered less invasive treatments for vascular disease. Technological innovation and a deep understanding of the medical marketplace and the needs of patients have made Cordis the world's leading developer and manufacturer of breakthrough stents, catheters and guidewires for interventional medicine, minimally invasive computer-based imaging, and electrophysiology.

Cardinal Health Careers

Joining Cardinal Health means becoming part of a team committed to pushing the boundaries of healthcare innovation and leadership. As a global leader in healthcare services and products, we offer unparalleled job opportunities designed to empower your career growth. Work You’ll Do At Cardinal Health, we are dedicated to creating an environment where professionals can thrive through diverse training and robust career development. We believe in fostering a culture that values diversity and drives innovation. Lead in a Dynamic Field Take a leading role in the healthcare industry with Cardinal Health. Our team is at the forefront of developing solutions that improve patient care and reduce costs. With positions ranging from logistics and operations to advanced analytics and pharmaceutical development, your work will directly impact lives around the world. Join Our Inclusive Team Be part of a culture that celebrates diversity and is committed to creating an inclusive environment for all employees. At Cardinal Health, we understand that unique perspectives lead to innovative ideas and better decision-making. Innovate with Us Our commitment to innovation is fundamental. Cardinal Health is a place where you can work with cutting-edge technology and collaborate with industry experts to deliver solutions that make healthcare safer and more effective. Grow Your Career Cardinal Health supports your professional growth with comprehensive benefits, continuous learning opportunities, and a clear path to advancement. From leadership programs to internships, we provide the tools to build your skills and advance your career. Explore Job Opportunities Whether you’re looking for an internship, a full-time position, or a leadership role, Cardinal Health offers a range of employment options to help you meet your career goals. Our hiring process is designed to match your skills and interests with the right opportunities within our company. Stay Connected Join Our Team Search for open positions that align with your skills and interests. We are always looking for passionate, curious, and solution-driven team players. Keep Up to Date Stay informed with career tips, insider perspectives, and industry-leading insights—all from the people who work here. Networking and Professional Development Enhance your career with our networking events, professional development sessions, and comprehensive benefits designed to boost your career journey. Job Alert Emails Customize your subscription to receive job alerts, the latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at Cardinal Health. Join Cardinal Health today and be part of a team that’s dedicated to improving the future of healthcare. Explore our careers page to find out how you can contribute to our mission and advance your professional journey.
Learn more about Cardinal Health
Size
47,300 employees
Market Cap
$20.8 billion
Industry
Healthcare
Net Income
$1.3 billion
Founded
1971
5 Year Trend
+6.9%
Revenue
$156.4 billion
NASDAQ
CAH
* Ladders Estimates

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