Director, Design Quality Engineering

What Quality Management contributes to Cardinal Health
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Provides strategic oversight, leadership, and direction within the Quality function.

Job Summary
The Director of Design Quality Management oversees the Quality Operations within Cardinal Health. This job supervises all forms of quality control inspection, sampling, testing, and control of components, products, and raw materials to meet established quality standards, either in the raw state or after various stages of manufacturing.

This leader is responsible for product and service quality including design control activities and risk management. Works cross-functionally in the development and implementation of prevention-based methodologies used in the design, manufacture, testing, and sustainability of capital equipment and disposable medical devices. This role is responsible for leading managers and individual contributors, budget management, strategic planning and risk-based decision making. This position interacts with leadership across the organization and is often tasked with cross-functional problem solving in sensitive situations while maintaining positive relationships.

Accountabilities

• Supports regulatory and filing needs for new product development.
• Sustains existing submissions and regulatory assessment of current products.
• Oversees the functional management of direct reports including but not limited to career development, succession planning to meet the organization's needs.
• Works with manufacturing and research managers to design, develop, and modify the products and facilities of the organization.
• Establishes short to midterm goals for quality management systems in both international and domestic locations.
• Aids in debugging and design reviews from a quality perspective, with good understanding of the product development life cycle process.
• Supports quality operations for global R&D activities, ensuring that proper compliance guidelines are in place and being followed.
• Leads quality investigations and process improvement for internally developed products at Cardinal R&D locations.
• Validates and qualifies external quality check processes and end-products for externally developed medical device products.
• Investigates product failures/complaints and audits processes to ensure QRA compliance in the engineering process.
• Collaborates with internal and external stakeholders to commercialize externally developed products.
• Demonstrates understanding of quality philosophies, principles, systems, methods, tools, and standards.
• Plans, controls, and assures product and process quality in accordance with quality principles, which can include process development, design control improvements, test method development and validations, process validation, and critical to quality activities.
• Applies problem solving and quality improvement tools and techniques, including corrective actions and how to overcome barriers to quality improvements.
• Acquires and analyzes data using appropriate standard quantitative methods to facilitate process analysis and improvements.
  

Qualifications

• 12+ years of experience highly preferred
• Bachelors degree in related field, or equivalent work experience, preferred.
• Strong preference for medical device industry experience
• Exhibits expertise in reliability, maintainability, and risk management, encompassing key terminology and definitions, modeling techniques, systems design, assessment tools, and reporting methods.
• Proven success building strong relationships and trust among cross functional key stakeholders.
• Skilled in working through complex issues and developing innovative solutions.
• Strong people leader who effectively coaches, leads, and mentors teams, driving high accountability.

Anticipated pay range: $114,200-$184,380
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

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

Application window anticipated to close: 05/15/2025 *If interested in opportunity, please submit application as soon as possible.

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.