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

• Leads regulatory submissions and filings to the relevant agencies for global products.
• Ensures product and filing compliance with local regulatory requirements.
• Validates products’ market opportunity (ability to commercialize) prior to filing.
• 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.
• Ensures the proper receipt of raw materials, testing, and final release of products at their assigned plant.
• Serves as the Head of Quality for the assigned plant and oversees all aspects of Quality Operations.
• Acts as management representative for FDA and applicable state and regulatory affairs.
• Investigates issues related to raw materials, production line efficiencies, and new supplier validation.
• 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.
• Identifies new software solutions and enhancement to current systems.
• Leads change management and general IT system maintenance including corrective and preventative action and audits.
• Validates systems and programs used within Cardinal Health’s Medical Segment.
• 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
• Bachelor’s 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