$105K – $135KMidFull Time
Quality Systems Manager, Medical Devices
As a Quality Systems Manager, you will lead the design, implementation, and continuous improvement of electronic Quality Management Systems (eQMS). This role is accountable for ensuring quality and regulatory compliance within the eQMS platform to support Cardinal Health. The role partners closely with IT, Engineering, PMO, Quality, Regulatory, Legal, and Product teams to ensure quality is operationalized across the organization and supports rapid innovation and scale.
Key Responsibilities
This Quality Systems Manager role is primarily responsible for oversight and governance of the eQMS systems which includes development, implementation, maintenance, and continuous improvement of the Quality Management Systems used to support our programs and ensuring sustained compliance with 21 CFR Part 820 / QMSR, ISO 13485, MDSAP, EU MDR and any other applicable regulations and standards.
Establish eQMS governance, decision rights, and escalation mechanisms to ensure consistent execution across products, programs, and geographies.
Support internal audits, external audits, regulatory inspections, and management reviews.
The role partners cross-functionally with IT, Quality, Operations, Engineering, and other functions to embed quality into all stages of the QMS programs.
Establish and maintain a global eQMS framework that supports multi-site operations, harmonization, and future growth, including acquisitions and integration efforts.
Implement, maintain, and optimize Global eQMS software, ensuring system effectiveness, data integrity, and user adoption.
Lead, coach, and mentor the QMS team, fostering a high-performing organization with strong accountability, engagement, and capability development
Recall Execution: Oversight of the recall process and partnering with the cross functional team for all GMPD field action executions. This includes, among other tasks, internal and external communication strategies, consignee management, reconciliation reporting and field action record keeping.
Regulatory Compliance: Ensuring all actions comply with FDA, ISO 14971, GMP/GDP regulations, and any applicable regulations/standards.
Qualifications & Experience
Bachelor’s of Information Management, Life Sciences, Quality, or a related technical discipline, preferred.
5-7+ years of experience in medical device quality systems, preferred
Demonstrated experience designing, implementing, and operating QMS compliant with 21 CFR Part 820 / FDA QMSR, ISO 13485, EU MDR, preferred
Experience with eQMS development and data integrity requirements, preferred
Strong hands-on experience with core QMS processes, including document control, CAPA, NCRs, audits, training, supplier quality management, and post-market surveillance, preferred
Strong cross-functional influence, communication, and stakeholder management skills in complex, matrixed organizations.
Pragmatic, systems-thinking mindset with a proven ability to operationalize QMS compliance in fast-paced, innovation-driven environments.
Anticipated salary range: $105,100 - $135,090
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: 5/7/2026 *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.
Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
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.
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