Quality Assurance Manager

What Quality Management contributes to Cardinal Health 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. 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 Medical, dental and vision coverage Paid time off plan Health savings account (HSA) 401(k) 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. Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law. #J-18808-Ljbffr